Formulations with colloidal silver

ABSTRACT

Colloidal silver particles are incorporated into emulsions and other compositions that find use, for example, as pharmaceutical and dermatological serums, creams, lotions and ointments.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.15/753,289, filed Feb. 17, 2018, which is a national phase applicationunder 35 U.S.C. § 371 of International Application No.PCT/US2016/047649, filed Aug. 18, 2016, which claims the benefit under35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/206,681filed Aug. 18, 2015, which each application is incorporated herein byreference in its entirety.

BACKGROUND OF THE INVENTION

The present disclosure relates generally to formulations comprisingsilver particles and the use thereof in, e.g., cosmetic, dermatologicand pharmaceutical formulations. For example, the present disclosureprovides emulsions and formulations thereof, and in particular emulsionsthat contain silver particles, and formulations containing said emulsionin useful compositions such as cosmetic and dermatologic formulations.

SUMMARY OF THE INVENTION

In one aspect, the present disclosure provides emulsion-containingformulations, methods for making such formulations, and methods of usingsuch formulations. Emulsions are currently found as part of manycosmetic, dermatologic and pharmaceutical formulations. The presentdisclosure provides improvements on these and other formulations thatincorporate emulsions as described herein. The following are exemplaryembodiments of the disclosure.

In one embodiment, the present disclosure provides a formulationcomprising silver particles and an emulsion phase. Optionally, one ormore of the following may further describe the formulation, where thefollowing are exemplary only: it (the formulation) is in the form of alotion, such as a skin lotion; it is in the form of a cream, such as askin cream; it is in the form of an ointment, such as a healingointment; it is in the form of a serum, such as an anti-aging serum, itis a cosmetic formulation; it is a dermatologic formulation; it is atherapeutic formulation; the silver particles range in size from 1-100nanometers; the silver particles comprises a silver core surrounded by amultivalent silver oxide coating comprised of Ag₄O₄ molecules; theformulation has a concentration of silver particles of 1-100 ppm; theformulation has a concentration of silver particles of 10-40 ppm; thesilver is characterized by particle size, and more than 50% of thesilver particles have a maximum dimension of less than 0.015micrometers; the formulation has a concentration of silver particles ofbetween about 1 to about 100, or about 5 to about 40 parts per million,wherein said silver is in the form of a stable and colorless colloidalsuspension of silver particles having an interior of metallic silver andan exterior surface of silver oxide, wherein at least 75% of the silverparticles have diameters between 0.005 micrometers and 0.015micrometers; the formulation comprises an oil, e.g., an oil selectedfrom coconut oil, hemp seed oil, argan oil, shea butter, sunflower seedoil, neem oil, jojoba oil, and sweet almond oil; the formulationcomprises a fatty acid, e.g., a fatty acid selected from C10-C28 fattyacids; the formulation comprises an emulsifying wax; the formulationcomprises a surfactant; the formulation comprises hyaluronic acid; theformulation comprises a pH adjusting agent, e.g., a pH adjusting agentselected from ethanolamine, diethanolamine and triethanolamine. Theformulation may provide one or more functional benefits, such ascontrolling, reducing or preventing acne, or providing lubrication as ina personal lubricant, as well as other functional benefits includingthose described herein.

In another embodiment, the present disclosure provides a method ofpreparing an emulsion, comprising combining an oil phase and a waterphase, where the water phase comprises silver particles. Optionally, oneor more of the following may further describe the method: the oil phaseis added to the water phase; the water phase is added to the oil phase,the product from the method is in the form of a serum, for example, ananti-aging serum having anti-aging ingredients, the product from themethod is in the form of a lotion, for example, a skin lotion; theproduct from the method is in the form of a cream, e.g., a skin cream;the product from the method is in the form of an ointment, e.g., ahealing ointment; the product from the method is a cosmetic formulation;the product from the method is a dermatologic formulation; the productfrom the method is a therapeutic formulation; the silver particles rangein size from 1 to 100 nanometers; the silver particles comprises asilver core surrounded by a multivalent silver oxide coating comprisedof Ag₄O₄ molecules; the formulation has a concentration of silverparticles of 1 to 100 ppm; the silver is characterized by particle size,and more than 50% of the silver particles have a maximum dimension ofless than 0.015 micrometers; the product from the method has aconcentration of silver particles of between about 5 parts per millionand 40 parts per million, wherein said silver is in the form of a stableand colorless colloidal suspension of silver particles having aninterior of metallic silver and an exterior surface of silver oxide,wherein at least 75% of the silver particles have diameters between0.005 micrometers and 0.015 micrometers; the method includes using anoil selected from coconut oil, hemp seed oil, argan oil, shea butter,sunflower seed oil, neem oil, jojoba oil, and sweet almond oil; themethod includes using a fatty acid, e.g., a fatty acid selected fromC10-C28 fatty acids; the method includes using an emulsifying wax; themethod includes using a surfactant; the method includes using hyaluronicacid (e.g., optionally having a molecular weight of less than 100,000Daltons in order to avoid product discoloration); the method includesusing a pH adjusting agent, e.g., a pH adjusting agent selected fromethanolamine, diethanolamine and triethanolamine.

In another embodiment, the present disclosure provides a method of usingthe silver particle-containing formulations disclosed herein. Forexample, the present disclosure provides a method of improving skincomprising applying to the skin an effective amount of a formulation asdescribed herein, or prepared as described herein.

In another aspect, the present disclosure provides oil-free compositionsthat comprise silver particles and optionally at least one activeingredient. For example, the present disclosure provides a personallubricant comprising silver particles, water and a thickening agent suchas hydroxyethylcellulose (HEC). As another example, the presentdisclosure provides an acne treatment composition comprising silverparticles, water, alcohol such as propylene glycol or polyethyleneglycol, and an exfoliant such as salicylic acid or glycolic acid.

The present invention provides silver containing compositions thatovercome problems associated with prior art silver containingcompositions. In one embodiment the compositions contain silver in the+2 oxidation state, particularly in association with metallic silver, toprovide potent antimicrobial properties. This high potency means thatlower amounts of silver particles may be utilized in the preparation ofthe personal care formulations, thus avoiding undesirable side-reactionsthat can occur with silver, e.g., discoloration of the formulation,color instability, rheology instability, and oxidation of components ofthe formulation. This Brief Summary has been provided to introducecertain concepts in a simplified form that are further described indetail below in the Detailed Description. Except where otherwiseexpressly stated, this Brief Summary is not intended to identify key oressential features of the claimed subject matter, nor is it intended tolimit the scope of the claimed subject matter.

The details of one or more embodiments are set forth in the descriptionbelow. The features illustrated or described in connection with oneexemplary embodiment may be combined with the features of otherembodiments. Thus, any of the various embodiments described herein canbe combined to provide further embodiments. Aspects of the embodimentscan be modified, if necessary to employ concepts of the various patents,applications and publications as identified herein to provide yetfurther embodiments. Other features, objects and advantages will beapparent from the description, the examples, and the claims.

DETAILED DESCRIPTION OF THE INVENTION

Briefly stated, in one embodiment the present invention providesemulsions that contain particulate silver. The emulsions may beformulated into a serum, a cream, a lotion, an ointment, etc. useful forany of, e.g., cosmetic, dermatologic or therapeutic purposes.

The present invention may be understood more readily by reference to thefollowing detailed description of the preferred embodiments of theinvention and the Examples included herein. It is to be understood thatthe terminology used herein is for the purpose of describing specificembodiments only and is not intended to be limiting. It is further to beunderstood that unless specifically defined herein, the terminology usedherein is to be given its traditional meaning as known in the relevantart. The headings used within this document are only being utilized toexpedite its review by the reader, and should not be construed aslimiting the invention or claims in any manner.

As used throughout this document, including the claims, the singularform “a”, “an”, and “the” include plural references unless indicatedotherwise. For example, “a” surfactant includes one or more surfactants.As another example, “an” antibiotic refers to one or more antibiotics.Another example is that “a” natural plant extract includes one or morenatural plant extracts. A composition that is disclosed to contain anamed component or functional ingredient may, but need not, containadditional components or functional ingredients that may or may not bespecifically identified herein. The terms composition and formulationare used interchangeably herein. It should also be noted that theconjunctive terms, “and” and “or” are generally employed in the broadestsense to include “and/or” unless the content and context clearlydictates inclusivity or exclusivity as the case may be. Thus, the use ofthe alternative (e.g., “or”) should be understood to mean either one,both, or any combination thereof of the alternatives. In addition, thecomposition of “and” and “or” when recited herein as “and/or” isintended to encompass an embodiment that includes all of the associateditems or ideas and one or more other alternative embodiments thatinclude fewer than all of the associated items or ideas.

Emulsions

As used herein, an emulsion refers to a mixture that includes twoimmiscible phases, a hydrophilic (aqueous) phase and hydrophobic (oil)phase. In an emulsion, one of the two immiscible phases is in the formof small droplets that are dispersed in the other phase. For example,the emulsion may be an oil-in-water emulsion, in which case the emulsionincludes the form of small droplets of oil dispersed throughout thewater phase. Another example is a water-in-oil emulsion, in which casethe emulsion includes the form of small droplets of water dispersedthroughout the oil phase. The two immiscible phase are typicallyliquids. See, e.g., emulsions as described in PCT publication nos.WO15014573, WO14012918, WO14013194, and WO13180157, as well as U.S.patent application publication nos. US2015050321 and US2013302385 forfurther descriptions of emulsion.

In addition to oil-in-water emulsions and water-in-oil emulsions,exemplary emulsions of the present disclosure include water-in-siliconeemulsions, silicone-in-water emulsions, water-in-oil-in-water, andoil-in-water-in-oil emulsions, and oil-in-water-in-silicone emulsions.The emulsion may be a microemulsion (see, e.g., EP2505180, US2014017185,US2011159104, CA2571906 and WO06136331) or a nanoemulsion (see, e.g.,WO14197008 and U.S. Pat. No. 8,956,597). The emulsion may be amacroemulsion (see, e.g., US20140135406 and WO14143728). The emulsionmay be a micro-scale heterogeneous emulsion (see, e.g., US2014335030).The emulsion may be a multiphase emulsion, for example awater-in-oil-in-water type, as disclosed in U.S. Pat. Nos. 4,254,105 and4,960,764. The emulsion may comprise an aqueous dispersion of siliconeelastomer particles (see, e.g., US 20150118320). The emulsion may be apost-foaming emulsion (see, e.g., US20150086500). The emulsion may be aninverse emulsion (see, e.g., WO14154700). These are examples of types ofemulsions that are provided by the present disclosure. However, unlikethe emulsions described in these documents, the emulsions of the presentdisclosure include particulate silver, which is typically present in theaqueous phase. Emulsions of the present disclosure may be prepared inanalogy to the recipes provided in these listed documents, but usingaqueous colloidal silver as described below, for some or all of theaqueous phase that is used in the recipes.

Colloidal Silver Particles

The term “colloidal silver” refers to a solution that can containvarious concentrations of ionic silver compounds, silver particles, orsilver compounds bound to proteins in water. In one embodiment,colloidal silver refers to particles which in whole or in part comprisesilver, where the particles are suspended in an aqueous medium.

The total amount of colloidal silver in a composition may be between 1ppm and 100 ppm. In optional embodiments, the content of colloidalsilver in the composition is about 30±5 ppm, or 25±5 ppm, or 20±5 ppm,or 15±5 ppm, or 10±5 ppm. As the particles become smaller, a givenconcentration of particles will represent a larger number of particles.In addition, the total surface area for a given particle concentrationwill increase. Therefore, particle size and range of particle size mayfurther characterize the compositions of the present invention. Infurther embodiments, the present disclosure provides that more than 50%of the particles have a maximum dimension less than 0.015 micrometers;or that more than 75% of the particles have a maximum dimension lessthan 0.015 micrometers; or that more than 90% of the particles have amaximum dimension less than 0.02 micrometers; or that more than 75% ofthe particles have a minimum dimension greater than 0.005 micrometers;or that more than 90% of the particles have a minimum dimension greaterthan 0.005 micrometers.

The particles may optionally be characterized in terms of valence of thesilver. In one embodiment, the silver particles include both silver inthe zero-valent state represented as [Ag(0)], i.e., metallic silver, anda coating of silver oxide in an oxidation state selected from Ag(I),Ag(II), and Ag(III). For example, the particles may have a coating ofsilver oxide, e.g., Ag₂O or Ag₄O₄. In one embodiment, the silver oxidein the particles may be primarily in the form of Ag₄O₄, i.e., silver IIoxide. In a molecule of this material two of the silver atoms are in the1+ state (silver I) while the other two silver molecules are in the 3+state (silver III). Under certain conditions these molecules can giverise to silver atoms or ions in the 2+ (silver II) state. Thus, thepresent disclosure provides silver particles comprising metallic silverand silver oxide, the silver oxide being selected from Ag₂O and Ag₄O₄.

In one embodiment, any of the formulations of the present disclosureinclude silver in the +2 (also known as 2+ or Ag (II)) oxidation state.It has been surprisingly found that the selection of silver particlescomprising silver in the +2 oxidation state affords a superiorformulation as disclosed herein. Silver particles in the +2 oxidationstate may be used in a low concentration that provides desirablebenefits for the formulation, e.g., desirable anti-microbial benefits,and this low concentration does not cause undesirable effects orside-reactions that are observed at higher silver concentration. Forexample, at high silver concentration, silver can cause oxidation ofsome of the components of a formulation, notably components that aresubject to oxidation. Components subject to oxidation include oils,particularly but not exclusively unsaturated oil, salts, acids such ashyaluronic acid and amino acids such a L-arginine, and fragrances thatinclude oxidizable groups such as aldehyde groups, to name a few. In oneembodiment, a formulation of the present disclosure contains silverparticles comprising silver in the +2 oxidation state, the particlesbeing present in the formulation within a stated concentration rangehaving a minimum and maximum concentration, where the minimumconcentration is selected from 0.01 ppm, or 0.02 ppm, or 0.03 ppm, or0.04 ppm, or 0.05 ppm, or 0.06 ppm, or 0.07 ppm, or 0.08 ppm, or 0.09ppm, or 0.1 ppm, or 0.2 ppm, or 0.3 ppm, or 0.4 ppm, or 0.5 ppm, or 0.6ppm, or 0.7 ppm, or 0.8 ppm, or 0.9 ppm, or 1 ppm, or 2 ppm, or 3 ppm,or 4 ppm, or 5 ppm, or 6 ppm, or 7 ppm, or 8 ppm, or 9 ppm, or 10 ppm,and the maximum concentration is selected from 1,000 ppm, or 500 ppm, or400 ppm, or 300 ppm, or 200 ppm, or 100 ppm, or 90 ppm, or 80 ppm, or 70ppm, or 60 ppm, 50 ppm, or 40 ppm, or 30 ppm, or 25 ppm, or 20 ppm, or15 ppm, or 10 ppm, where ppm has its standard meaning and refers toparts per million, i.e., weight parts of silver particles per onemillion weight parts of the formulation, e.g., 10 ppm refers to 10 gramsof silver particles per every 1 million grams of formulation. Exemplarysilver particle concentrations of 1-100 ppm, or 0.5-500 ppm, or0.1-1,000 ppm, or less than 20 ppm, or less than 50 ppm, or 10-35 ppmare provided by the present invention, as well as concentrations within1-100 ppm as mentioned previously. A benefit of using silver (II) at lowconcentration includes providing a product with a longer shelf life,e.g., providing a product that retains the desired performance benefitfor a longer period of time, or providing a product that retains itsconsistency for a longer period of time, or providing a product thatretains its original color for a longer period of time, since unwantedoxidation reactions that can shorten shelf life and/or damage theconsistency of the product, and/or cause discoloration, are reduced. Forexample, the formulation may have at least about 10 ppm silver particlesin order to provide good antimicrobial effectiveness but less than about32 ppm silver particles in order to avoid discoloration of theformulation. Consistency in coloration and/or rheology over time may bemeasured while the formulation sits at room temperature, for exampleabout 23° C., for a period of time, for example, 1 day, 2 days, 3 days,4 days, 5 days, 6 days, 1 week, 2 weeks, 3 weeks, 4 weeks, 1 month, 2months, 3 months, 4 months, 5 months or 6 months. Coloration andrheology may also be evaluated relative to target values. For example,if a white product is desired, and the silver concentration is too high,then a grey or yellowish product may result, indicating that too high ofa concentration of silver is present in the formulation. In oneembodiment, the silver particles used in the present formulations do notinclude any substantial amount of silver in the +1 oxidation state, butonly has silver in the silver metal or +2 oxidation state, or if silverin the +1 oxidation state is present, it is present in a minor amount,i.e., less than the amount of silver present in the +2 oxidation state.

In one embodiment, the particles contain a thin multivalent silver oxidecoating, built of numerous Ag₄O₄ molecules which surround a metallicnano-sized silver core. With the Ag₄O₄ coating, the nano silver particleis attracted to the surrounding water molecules, and as such, becomespart of the structure of the water. This makes the silver much morestable and bioavailable than other forms of silver.

Within optional embodiments of the invention these particles can rangein size from 1-100 nanometers, or from 1-10 nanometers, or from 5-7nanometers. Moreover, within preferred embodiments the particles aresurrounded by a multivalent silver oxide coating comprised of Ag₄O₄molecules.

In one embodiment, the compositions of the present disclosure includeionic silver, however in another embodiment, the compositions of thepresent disclosure do not include ionic silver, or else they containminimal amounts of ionic silver. Ionic silver may be omitted fromcompositions of the present disclosure in order to avoid silvermetabolism, which may lead to silver being bound up in the body andcausing a skin condition known as Argyria, otherwise known as the blueman's syndrome.

In one embodiment, the compositions of the present disclosure includesilver bound to protein, however in another embodiment, the compositionsof the present disclosure do not include silver bound to protein, orelse they contain minimal amounts of silver bound to protein.Protein-bound silver, also sometimes referred to as mild silverproteins, are another form of ionic silver. Because ionic forms ofsilver are not generally stable, they are sometimes bound to a proteinto provide desired stability. However, as a consequence of binding withprotein, the silver ion is less functional and useful than traditionalionic silver ions, and accordingly may be omitted from compositions ofthe present disclosure.

Exemplary aqueous compositions comprising colloidal silver particles aredescribed in, and may be prepared by techniques disclosed in U.S. Pat.Nos. 6,214,299; 6,743,348; 7,135,195; and 8,535,728 as well as U.SPublication No. 2011/0262556. For example, the preparation of acomposition comprising colloidal silver particles may utilize anelectrochemical cell comprising electrodes. The process comprises thesteps of: (a) placing a silver electrode in contact with a quantity ofhigh purity water; (b) conveying electrical current through the silverelectrode to thereby separate particles of silver from said silverelectrode in a manner sufficient to cause production of suspended silverparticles within the water; and (c) agitating the water during saidproduction of suspended silver particles to thereby disperse the silverparticles into a more uniform concentration within said water such thata higher quantity of colloidal silver particles can be produced perbatch.

As another example, the preparation of a composition comprisingcolloidal silver particles may comprise the steps of: (a) establishingan electrical circuit comprising a current source, and a first conductorelectrically connected to said current source and a second conductorelectrically connected to said current source, wherein said firstconductor is disposed spaced apart from said second conductor, andwherein at least one of the conductors is made of elemental silver; (b)closing the circuit by placing the first conductor and the secondconductor in communication with a fluidic resistor; (c) operating thecurrent source to supply alternating current simultaneously to the firstconductor and the second conductor such that voltage is increasing anddecreasing within the first and second conductors in alternating tandemto thereby cause silver particles to separate from the first electrodeand enter the fluidic resistor and become disposed in suspension withinsaid fluidic resistor; and (d) selectively adjusting the electrodes bymoving them toward the fluidic resistor to compensate for decrease inelectrode length due to gradual separation of silver particles therefromto thereby prevent arcing from occurring between the electrodes and saidfluidic resistor.

Other suitable colloidal silver particles and their preparation aredescribed in, e.g., PCT Publication No. WO 2009/009143 and USPublication No. 2010/0187091.

In one embodiment, the colloidal silver particles are stable inessentially pure water without surfactants, etc. Additionally, or inanother embodiment, the solution of colloidal silver particles isessentially colorless. In another embodiment, the colloidal silverparticles are in saline. In another embodiment, the colloidal silverparticles are in combination with electrolytes needed by a body, e.g.,potassium and magnesium. In one embodiment, the colloidal silverparticles are in saline, and the saline contains electrolytes. In oneembodiment, the composition (e.g., aqueous composition, salinecomposition, etc.) contains colloidal silver particles at a lowerconcentration of 0.1 ppm, or 0.5 ppm, or 1 ppm, or 10 ppm, and at anupper concentration of 1,000 ppm, or 500 ppm, or 100 ppm. For example,concentrations of 1-100 ppm, or 0.5-500 ppm, or 0.1-1,000 ppm areprovided by the present invention, as well as concentrations within1-100 ppm as mentioned previously.

Composition Components

As stated above, the present invention provides emulsions whichincorporate colloidal silver, preferably in particulate form, and whichare particularly useful as cosmetic, dermatologic or therapeuticformulations, particularly in the form of creams, serums, lotions,ointments, and the like. The silver is typically utilized as an aqueouscomposition, e.g., the silver particles are dispersed and suspended inwater, and such a composition can be used to provide the aqueouscomponent of an emulsion, such as an oil-in-water or water-in-oilemulsion. In addition to the colloidal silver, which has been discussedabove, the emulsions may be prepared from the following ingredients,where the identified ingredients are not the exclusive ingredients thatmay be present in the emulsion, but rather are options that may beemployed in order to prepare the desired serum, lotion, cream, ointmentetc. that contains an emulsion.

The compositions of the present disclosure may contain an emulsifyingwax. Emulsifying waxes are a commonly used substance in a cosmeticformulations. Emulsifying wax is useful for the blending of creams,lotions and other fluid cosmetics which contain oil (a hydrophobicphase) and water (a hydrophilic phase). Emulsifying wax brings these twocomponents, the oil phase and the water phase, into a single phase andmaintains those incompatible materials as an emulsion phase. An emulsionis a system consisting of a liquid dispersed in an immiscible liquid,where immiscible means not compatible, i.e., not able to mix together tomake a solution. Emulsifying wax assists in improving the consistencyand texture of final products without leaving a greasy film on the outerskin after application. It also acts as a mild stabilizer and can impartthickness to a formulation, depending on how much wax is used.Emulsifying wax is recognized in the United States Pharmacopeia-NationalFormulary (USP-NF).

In one embodiment, this wax contain fats and esters, from eithervegetable or animal sources. In one embodiment, the emulsifying wax isfrom plant sources. The wax may take the form of flakes or powder orshavings, for example. The following are exemplary emulsifying waxes: 1)emulsifying Wax NF (national formulary), typically used at aconcentration of 3 and 6% of the total weight of the formulation,although more or less may be used; 2) ceterayl alcohol/cetereth 20 maybe used to prepare lotions, typically at a concentration of 2-6%, andmay be used in combination with other emulsifying waxes. At higherconcentrations, this material may be used for thicker, waxier creams; 3)cetearyl alcohol is a fatty alcohol derived from natural oils and fats(cetyl and stearyl alcohol) that can be used to thicken and stabilizeformulations. Cetearyl alcohol may impart an emollient feel to the skin,and is typically used at a concentration of 1-25%; 4) glyceryl stearateis an emulsifier and an emulsion stabilizer. It is typically used incombination with a second emulsifier, such as POLYSORBATE 20 orCETEARETH 20. A typical concentration range of glyceryl stearate in aformulation is 0.1-3%; 5) PLOYSORBATE 20 is another oil in wateremulsifier/solubilizer; 6) CETERETH 20 is useful in preparingoil-in-water emulsions, where it provides good stability, especially incombination with a second emulsifier such as glyceryl stearate.

Emulsifying wax may be obtained from many suppliers. For example,Lotioncrafter (Eastsound, Wash.) offers many emulsifying waxes,including emulsifying wax NF which is available as white pastilleshaving an HLB value of 14.9, and a recommended use rate of 2-25%,usually 3-5% for lotions and 5-10% for creams. They also offer mixturesof cetearyl alcohol (and) polysorbate 60 or emulsifying wax NF. See alsoPCT publication no. WO14134732.

In lieu of, or in addition to, an emulsifying wax, the compositions ofthe present invention may contain a surfactant. Suitable surfactantsinclude anionic, cationic, amphoteric, zwitterionic and non-ionic,including those listed in U.S. Pat. No. 6,197,319. The surfactantfunctions to stabilize an emulsion between oil and water phases.Exemplary surfactants include, without limitation, saccharide andpolysaccharide esters and ethers, such as sucrose stearate, sucrosecocoate and sorbitan stearate; oxyethylenated and/or oxypropylenatedethers of polyols such as glycerol; fatty acid esters of polyethyleneglycol such as PEG-50 stearate; phosphoric esters such as oleth-10phosphate and salts thereof, such as diethanolamine salts;oxyethylenated and/or oxypropylenated ethers of fatty alcohols such asceteareth-30; alkyl ether sulphates such as sodium lauryl ethersulphate; isethionates; betaine derivatives; and mixtures thereof.

Further examples of nonionic surfactants include polyoxyethylene laurylethers; polyoxyethylene alkylphenol ethers; polyoxyethylene alkylesters; polyoxyethylene sorbitan alkyl esters; polyethylene glycol(PEG); polypropylene glycol; diethylene glycol; ethoxylatedtrimethylnonanols; silicone alkanolamides; polyoxyethylene alkyl ethers;silicone esters; silicone glycosides; other fatty acid esters of polyolssuch as sorbitol and glyceryl mono-, di-, or tri-oleates or stearates;glyceryl or polyethylene glycol laurates; polyoxyethylene sorbitanmonoleates; fatty acid esters of polyethylene glycol such as PEGmonostearate and PEG monolaurate); polyoxyalkylene-substituted silicones(rake or ABn types); and polyoxyethylenated fatty acid esters, e.g.,polyoxyethylenated stearate or oleate esters of sorbitol.

Additional exemplary anionic surfactants include amino acid derivativessuch as N-acylglutamates, N-acylgly-cinates and acylsarcosinates;taurates and N-acyl N-methyltaurates; carboxylates such as sodium2-(2-hydroxyalkyloxy)acetate; alkyl sulfates, alkyl ether sulfates andoxyethylenated derivatives thereof; isethionates and N-acylisethionates;sulfosuccinates; alkylsulfoacetates; and fatty acid soaps, and mixturesthereof.

Additional examples of amphoteric and zwitterionic surfactants includebetaines and N-alkylamidobetaines; sultaines; alkylpolyaminocarboxylates; and alkylamphoacetates. The compositions of thepresent disclosure may include any one or more of these anionic,cationic and amphoteric surfactants.

The compositions of the present disclosure may contain an oil. The oilmay be a synthetic oil or a natural oil such as coconut oil. Coconut oilis advantageously included in personal care compositions because itreportedly has moisturizing, skin softening, anti-aging, andanti-microbial properties. The coconut oil may be virgin grade and/orcold pressed. Another suitable oil is hemp seed oil, optionally coldpressed and/or unrefined. Hemp seed oil reportedly has the benefits ofbeing a natural SPF 6, functions as an aid to Vitamin D absorption,reduces skin pore size, and has a high concentration of Omega 6 andOmega 3 which help rebuild epidermal lipids. Another suitable oil isargan oil from the argan tree. Argan oil reportedly has the benefits ofbeing a natural SPF 30, has a light consistency similar to human sebum,contains vitamin E and essential fatty acids, reduces inflammation,minimizes the appearance of wrinkles and blemishes, heals scars due tocontaining triterpenoids, has disinfectant and anti-fungal propertiesmaking it helpful for cleansing, and a pleasant odor. Another suitableoil is shea butter. Shea butter reportedly has a natural SPF rating of6, contains Vitamin E, has anti-inflammatory properties, may treateczema, psoriasis, bites, cuts, cracks, burns, etc., has moisturizingproperties as well as skin strengthening and regenerating properties,and stimulates collagen production. Another suitable oil is sunflowerseed oil. Sunflower seed oil reportedly has a light consistency, similarto human sebum, contains vitamins E, A, and D as well as essential fattyacids and carotenoids. Another suitable oil is neem oil (azadirachtaindica). Neem oil reportedly has a Natural SPF 15 rating, as well ashaving antiseptic, antiviral, anti-bacterial, anti-fungal, andinsecticidal properties. Another suitable oil is jojoba oil, which istechnically a liquid wax ester. Jojoba oil is reportedly a natural SPF4+, has medium consistency very similar to human sebum, and has bothanti-bacterial and anti-inflammatory properties. Yet another suitableoil is sweet almond oil. Sweet almond oil reportedly has a natural SPF5, a light to medium consistency somewhat similar to human sebum, andcontains calcium, potassium, magnesium, as well as Vitamins E, A, B1,B2, and B6.

The oil may be a so-called essential oil, which refers to a natural oiltypically obtained by distillation and having the characteristicfragrance of the plant or other source from which it is extracted,sometimes used for aromatherapy. Examples of essential oils includeAllspice essential oil (botanical name: Pimenta officinalis), Aniseed(Anise) essential oil (botanical name: Pimpinella anisum), Basilessential oil (botanical name: Ocimum basilicum), Basil essential oil(botanical name: Ocimum basilicum), Bergamot essential oil (botanicalname: Citrus bergamia), Black Pepper (Piper nigrum) essential oil(botanical name: Piper nigrum), Blue Tansy (Tanacetum annuum) essentialoil (botanical name: Tanacetum annuum), Cajeput essential oil (botanicalname: Melaleuca cajuputi), Cajeput essential oil (botanical name:Melaleuca cajuputi), Camphor essential oil (botanical name: Cinnamomumcamphora), Carrot Seed essential oil (botanical name: Daucus carota),Catnip essential oil (botanical name: Nepeta cataria), CedarwoodAtlantica essential oil (botanical name: Cedrus atlantica), CedarwoodHimalayan essential oil (botanical name: Cedrus deodora), CedarwoodVirginian essential oil (botanical name: Juniperus virginiana),Chamomile German (Blue) essential oil (botanical name: Matricariachamomilla), Chamomile Roman essential oil (botanical name: Chamaemelumnobile), Cinnamon Bark essential oil (botanical name: Cinnamomum verum),Cinnamon Cassia essential oil (botanical name: Cinnamomum cassia),Cinnamon Leaf essential oil (botanical name: Cinnamomum verum),Citronella essential oil (botanical name: Cymbopogon winterianus), ClarySage essential oil (botanical name: Salvia sclarea), Clove Bud essentialoil (botanical name: Syzygium aromaticum), Coffee essential oil(botanical name: Coffea Arabica), Copaiba Balsam essential oil(botanical name: Copaifera officinalis), Coriander essential oil(Botanical name: Coriandrum sativum), Cypress essential oil (botanicalname: Cupressus sempervirens), Dill Weed essential oil (botanical name:Anethum graveolens), Eucalyptus (Lemon) essential oil (botanical name:Eucalyptus citriodora), Eucalyptus globulus essential oil (botanicalname: Eucalyptus globulus), Eucalyptus radiata essential oil (botanicalname: Eucalyptus radiate), Fennel (Sweet) essential oil (botanical name:Foeniculum vulgare dulce), Fir Needle essential oil (botanical name:Abies sibirica), Frankincense carteri essential oil (botanical name:Boswellia carteri or Boswellia sacra), Frankincense frereana essentialoil (Botanical name: Boswellia frereana), Frankincense serrata essentialoil (Botanical name: Boswellia serrata), Garlic essential oil (botanicalname: Allium sativum), Geranium Bourbon essential oil (botanical name:Pelargonium×asperum), Geranium Egyptian essential oil (botanical name:Pelargonium×asperum), Ginger Root Extract (botanical name: Zingiberofficinalis), Grapefruit Pink essential oil (botanical name:Citrus×paradise), Helichrysum italicum essential oil (botanical name:Helichrysum italicum), Helichrysum splendidum essential oil (botanicalname: Helichrysum splendidum), Jasmine Essential Oil (botanical name:Jasminum grandiflorum), Juniper Berry essential oil (botanical name:Juniperus communis), Laurel Leaf essential oil (botanical name: Laurusnobilis), Lavandin essential oil (botanical name: Lavandula intermedia),Lime essential oil (botanical name: Citrus aurantifolia), Mandarinessential oil (botanical name: Citrus reticulate), Marjoram essentialoil (botanical name: Origanum majorana), May Chang essential oil(botanical name: Litsea cubeba), Myrrh essential oil (botanical name:Commiphora myrrha), Neroli essential oil (botanical name:Citrus×aurantium), Niaouli essential oil (botanical name: Melaleucaquinquenervia), Nutmeg essential oil (botanical name: Myristicafragrans), Orange (Blood) essential oil (botanical name: Citrussinensis), Orange (Sweet) essential oil (botanical name: Citrussinensis), Oregano (Origanum) essential oil (botanical name: Origanumvulgare), Palmarosa essential oil (botanical name: Cymbopogon martini),Patchouli (Dark) essential oil (botanical name: Pogostemon cablin),Pepper, Black essential oil (botanical name: Piper nigrum), Peppermintessential oil (botanical name: Mentha×piperita), Petitgrain essentialoil (botanical name: Citrus aurantium), Pine essential oil (botanicalname: Pinus silvestris), Ravensara essential oil (botanical name:Ravensara aromatic), Rosalina essential oil (botanical name: Melaleucaericifolia), Rose (botanical name: Rosa×damascene), Rosemary essentialoil (botanical name: Rosmarinus officinalis), Sage (Dalmatian) essentialoil (botanical name: Salvia officinalis), Sandalwood (Australian)essential oil (botanical name: Santalum spicatum), Spearmint essentialoil (botanical name: Mentha spicata), Spruce essential oil (botanicalname: Picea mariana), Tangerine essential oil (botanical name: Citrusreticulate), Tansy (Blue) essential oil (botanical name: Tanacetumannuum), Tea Tree essential oil (botanical name: Melaleucaalternifolia), Thyme (Red) essential oil (botanical name: Thymusvulgaris), Turmeric essential oil (botanical name: Curcuma longa),Vanilla Oleoresin (botanical name: Vanilla planifolia), Vetiveressential oil (botanical name: Vetiveria zizanoides), and Wintergreenessential oil (botanical name: Gaultheria procumbens). These areexemplary oils that may be included in a formulation of the presentdisclosure.

The compositions of the present disclosure may contain a fatty acid. Thefatty acid may have from about 10 to about 28 carbon atoms, i.e., be aC10-C28 fatty acid. For example, the fatty acid may be a saturated fattyacid having from about 10 to about 28 carbon atoms. The saturated fattyacid may be linear, where examples of linear saturated fatty acidsinclude capric acid (decanoic acid), undecylic acid (undecanoic acid),lauric acid (dodecanoic acid), tridecyl acid (tridecanoic acid),myristic acid (tetradecanoic acid), pentadecylic acid (pentadecanoicacid), palmitic acid (hexadecanoic acid), margaric acid (heptadecanoicacid), stearic acid (octadecaonic acid), nonadecylic acid (nonadecanoicacid), arachidic acid (eicosanoic acid), heneicosylic acid(heneicosanoic acid), behenic acid (docosanoic acid), tricosylic acid(tricosanoic acid), lignoceric (tetracosanoic acid), pentacosylic acid(pentacosanoic acid), cerotic acid (hexacosanoic acid), heptacosylicacid (heptacosanoic acid), and montanic acid (octacosanoic acid), whereterms in parentheses are alternative names.

Alternatively, the fatty acid may be an unsaturated fatty acid. Examplesof unsaturated fatty acids include, without limitation, α-linolenicacid, stearidonic acid, eicosapentaenoic acid, docosahexaenoic acid,linoleic acid, γ-linolenic acid, arachidonic acid, meat,docosatetraenoic acid, palmitoleic acid, vaccenic acid, paullinic acid,oleic acid, elaidic acid, gondoic acid, erucic acid, nervonic acid, andmead acid.

The compositions of the present disclosure may contain a moisturizingagent. Exemplary moisturizing agents include, without limitation,glycerin and other polyols such as sorbitol and trehalose, lowermolecular weight aliphatic diols such as butylene glycol and propyleneglycol, polyoxyethylene polymers such as polyethylene glycol (PEG) 200and PEG400, hyaluronic acid and derivatives thereof, and urea.

In one embodiment the hyaluronic acid has a molecular weight of about10,000 Daltons to about 1,100,000 Daltons. When the molecular weight ofthe hyaluronic acid is less than about 10 k Daltons, theviscosity-enhancing effect of the hyaluronic acid is below a desiredamount for a creamy formulation, and when the molecular weight of thehyaluronic acid is greater than about 1.1 million Daltons, the colorstability of the formulation is poor. A desired range of molecularweight for the hyaluronic acid component of a formulation of the presentdisclosure that includes silver particles is about 12,000 Daltons toabout 1.1 million Daltons. In one embodiment, a formulation contains twodifferent hyaluronic acid polymers, one having a molecular weight ofabout 12,000 Daltons and the other having a molecular weight of about1,1000,000 Daltons. In one embodiment, molecular weight refers to weightaverage molecular weight.

In one embodiment the hyaluronic acid is present in a formulation of thepresent disclosure at a concentration of 0.1 wt % to 2.5 wt %, with themaximum concentration optionally being 2.2 wt %, or 2.1 wt %, or 2.0 wt%, or 1.9 wt %, or 1.8 wt %, or 1.7 wt %, or 1.6 wt %, or 1.5 wt %. Whentoo much hyaluronic acid is present in a silver-containing formulationof the present disclose then discoloration of the formulation may beobserved. When the concentration of hyaluronic acid is less than 0.1 wt%, or less than 0.2 wt %, or less than 0.25 wt %, or less than 3 wt %,then the moisturizing efficacy of the formulation is reduced, sincehyaluronic acid is a good moisturizing agent.

The compositions of the present disclosure may contain an emollient.Emollients, as used herein, refer to materials used for the preventionor relief of dryness, as well as for the protection of the skin.Examples of emollients include, without limitation, stearyl alcohol,glycerol monoricinoleate, glycerol monostearate, mink oil, cetylalcohol, isopropyl isostearate, stearic acid, isobutyl palmitate,isocetyl stearate, oleyl alcohol, isopropyl luarate, hexyl laurate,decyl oleate, octadecan-2-ol, isocetyl alcohol, eicosanylalcohol,behenyl alcohol, cetyl palmitate, silicone oils such asdimethylpolysiloxane, di-n-butyl sebacate, isopropyl myristate,isopropyl palmitate, isopropyl stearate, butyl stearate, polyethyleneglycol, triethylene glycol, lanolin, cocoa butter, corn oil, cotton seedoil, tallow, lard, olive oil, palm kernal oil, rapeseed oil, safflowerseed oil, evening primrose oil, soybean oil, sunflower seed oil, avocadooil, olive oil, sesame seed oil, coconut oil, arachis oil, castor oil,acetylated lanolin alcohols, petroleum jelly, mineral oil, butylmyristate, isostearic acid, palmitic acid, 5 isopropyl linoleate, lauryllactate, myristyl lactate, decyl oleate, and myristyl myristate.

The compositions of the present disclosure may contain a pH adjustingagent, also sometimes referred to as a pH controlling agent, and alsoreferred to as an acid or a base. Examples of such agents include acids,such as water soluble acids which may be an organic acid or an inorganic(mineral) acid. Examples include, without limitation, hydrochloric acid,sulphuric acid, phosphoric acid, monocarboxylic acid such as acetic acidand lactic acid, and polycarboxylic acids such as succinic acid, adipicacid, and citric acid. The pH adjusting agent may be a base, which maybe an organic or inorganic base. Examples include water soluble organicbases such as ethanolamine, diethanolamine and triethanolamine, as wellas the inorganic bases sodium hydroxide and potassium hydroxide, to namea few.

The compositions of the present disclosure may contain vitamin orvitamin derivative. For example, the vitamin or vitamin derivative maybe lipid soluble, where examples include, without limitation, retinol(vitamin A), ergocalciferol (vitamin D2), cholecalciferol (vitamin 5D3), phytonadione (vitamin K1), and tocopherol (vitamin E). As anotherexample, the vitamin or vitamin derivative may be water-soluble, whereexamples include, without limitation, ascorbic acid (vitamin C), thiamin(vitamin B1) niacin (nicotinic acid), niacinamide (vitamin B3),riboflavin (vitamin B2), pantothenic acid (vitamin BS), biotin, folicacid, pyridoxine (vitamin B6), and cyanocobalamin (vitamin B12).

Other exemplary vitamins that may be included in the compositions of thepresent disclosure include, without limitation, tocopheryl nicotinate,tocophereth-18, tocopheryl linoleate (vitamin E linoleate),tocophereth-50 (ethoxylated vitamin E derivatives), retinyl acetate(vitamin A acetate), PPG-2 tocophereth-5, PPG-5 tocophereth-2, PPG-10tocophereth-30, PPG-20 15 tocophereth-50, tocophereth-12, PPG-30tocophereth-70, retinyl propionate (vitamin A propionate), PPG-70tocophereth-100 (propoxylated and ethoxylated vitamin E derivatives),retinyl palmitate 10 (vitamin A palmitate), tocopheryl succinate(vitamin E succinate), sodium tocopheryl phosphate, ascorbyl palmitate,retinyl linoleate (vitamin A linoleate), ascorbyl glucoside, ascorbyldipalmitate, tocophereth-5, tocophereth-10, ascorbyl tocopheryl maleate,ascorbyl tetraisopalmitate, tetrahexadecyl ascorbate, tocopheryl acetate(vitamin E acetate), potassium ascorbyl and tocopheryl phosphate. See,e.g., US2013331428 AA, for formulations that include retinoids. In oneembodiment the vitamin, e.g., vitamin E, is present in the formulationat a concentration of at least about 0.5 wt % but less than about 1.0 wt%.

The compositions of the present disclosure may contain a sunscreenagent. Examples include, without limitation, aminobenzoic acid,cinoxate, diethanolamine 10 methoxycinnamate, digalloyl trioleate,dioxybenzone, ethyl 4-[bis(Hydroxypropyl)] aminobenzoate, ethyl hexylmethoxycinnamate, glyceryl aminobenzoate, homosalate, lawsone withdihydroxyacetone, menthyl anthranilate, octocrylene, octyl salicylate,phenylbenzimidazole sulfonic acid, red petrolatum, sulisobenzone,titanium dioxide, and trolamine salicylate.

The compositions of the present disclosure may contain a UV absorber.The UV absorber may be PABA or a PABA derivative such as allatoin PABA,butyl PABA, dimethyl PABA ethyl cetearyldimonium tosylate, ethyldihydroxypropyl PABA, ethyl PABA, glyceryl PABA, octyl dimethyl PABA,propyl dihydroxypropyl PABA, PEG-25 pentyl dimethyl PABA, and triPABApanthenol. The UV absorber may be a cinnamate compound such asDEA-methoxycinnamate, diisopropyl ethyl cinnamate, diisopropyl methylcinnamate, ethyl 25 diisopropylcinnamate, ethyl methoxycinnamate,glyceryl octanoate dimethoxycinnamate, isobutyl methoxycinnamate,isopropyl methoxycinnamate, isoamyl p-methoxycinnamate, ethyl hexyl 30methoxycinnamate, and potassium methoxycinnamate. The UV absorber may bea salicylate compound such as benzyl salicylate, glycol salicylate,isopropylbenzyl salicylate, menthyl salicylate, octyl salicylate, propylsalicylate and TEA-salicylate. See, e.g., U.S. Pat. No. 8,486,463.

These sunscreen agents and/or UV absorbers may absorb ultraviolet lightbetween about 290-320 nanometers (the UV-B region) and/or absorbultraviolet light in the range of 320-400 nanometers (the UV-A region).

The compositions of the present disclosure may contain a skinprotectant. Examples include, without limitation, allantoin, an aluminumsalt such as aluminium acetate, aluminium hydroxide and aluminiumsulfate, calamine, cocoa butter, cod liver oil, colloidal oatmeal,dimethicone, glycerin, kaolin, lanolin, mineral oil, petrolatum, sharkliver oil, sodium bicarbonate, talc, witch hazel, and a zinc salt suchas zinc acetate, zinc carbonate and zinc oxide.

The compositions of the present disclosure may contain preservativeand/or a biocide. Examples include, without limitation, parabenderivatives, hydantoin derivatives, chlorhexidine and its derivatives,imidazolidinyl urea, phenoxyethanol, salicylate derivatives, triclosan,ciclopirox olamine, hexamidine, oxyquinoline and its derivatives,PVP-iodine, and zinc salts and derivatives such as zinc pyrithione.

The compositions of the present disclosure may contain a therapeuticagent, in which case the composition may be used to deliver atherapeutic agent to a subject in need thereof. Exemplary therapeuticagents include, without limitation, acetominophen, amphetamines,anesthetics, aspirin, barbiturates, benzocaine, benzodiazepine, “caine”anesthetics, cancer-treating agents, catecholamines, cephalosporins,codeine, diclofenac, dipyridamole, epinephrine, hormones (see, e.g., PCTpublication WO 2015/038951), indomethicane, lidocaine, macrolides,morphine, NSAIDs, opiods, penicillins, perbuterol, procaine,prostaglandins, scopolamine, steroids, sulphonamides, suramin,tetracyclines, thiopental, ticonazole, and theophylline. In oneembodiment the composition comprises lidocaine in an anestheticallyeffective amount for a topical anesthetic.

The compositions of the present disclosure may be used to combat acne,i.e., to prevent, treat or control the occurrence of acne, in which casethe compositions will contain one or more anti-acne therapeutic agents.Acne medications work by reducing oil production, speeding up skin cellturnover, fighting bacterial infection and/or reducing inflammation. Inone embodiment the composition comprises a retinoid. Retenoid drug arederived from vitamin A and include tretinoin (such as in Avita andRetin-A), adapalene (such as in Differin) and tazarotene (such as inTazorac and Avage). Creams and lotions containing such an ingredientgenerally work by preventing plugging of the hair follicles. In anotherembodiment the composition comprises an antibiotic. These work bykilling excess skin bacteria and reducing redness. In anotherembodiment, the composition contains benzoyl peroxide. Benzoyl peroxidehas antibacterial, peeling (keratolytic), and drying actions. Forexample, the composition may contain both an antibiotic and benzoylperoxide, where the benzoyl peroxide reduces the likelihood ofdeveloping antibiotic resistance. Examples include clindamycin withbenzoyl peroxide (such as in Benzaclin, Duac, Acanya) and erythromycinwith benzoyl peroxide (such as in Benzamycin). In another embodiment,the composition contains salicylic acid. Topical administration ofsalicyclic acid creates a mild chemical peel, whereby the skin cells inthe top layers of the skin are removed. The compositions of the presentdisclosure may contain an exfoliating agent which removes dead skincells from the epidermis, the top layer of the skin, where suitableexfoliating agents include salicyclic acid as mentioned previously, andalso include other effective exfoliating agents such as glycolic acidand lactic acid.

The present disclosure provides an acne treatment or combattingcomposition comprising silver particles and one or more of water,alcohol such as propylene glycol or polyethylene glycol, and anexfoliant such as salicylic acid or glycolic acid. In preparing anacne-combatting formulation of the present invention, the formulationcontains silver particles, such as silver particles with Ag +2 asmentioned elsewhere herein. In one embodiment, the silver is present ata concentration of at least about 1 ppm, or 5 ppm, or 8 ppm, or 10 ppm,or 12 ppm, or 15 ppm, and at a concentration of less than about 50 ppm,or 45 ppm, or 40 ppm, or 35 ppm, or 32 ppm, or 30 ppm, or 25 ppm. Forexample, the formulation may contain between 10 and 32 ppm of silverparticles. As the concentration of silver is decreased, theantimicrobial effectiveness of the silver undesirably decreases, and asthe concentration of the silver is increased, the light sensitivity ofthe formulation undesirably increases, which leads to discoloration ofthe formulation to, e.g., a gray color. The acne-combatting formulationmay also contain salicylic acid at a concentration of about 0.5% toabout 2.0%, e.g., from about 0.2%, or from about 0.3%, or from about0.4%, or from about 0.5%, or from about 0.6%, to about 3.0%, or to about2.5%, or to about 2.0%, or to about 1.5%. As used herein and through thespecification, % values refer to weight percent of the total weight ofthe formulation. As the concentration of salicylic acid is decreased,the exfoliating properties of salicylic acid undesirably diminishes,while if the concentration of salicylic acid is increased, the salicylicacid does not remain suspended or solubilized in the formulation. Anacne-combatting formulation may also contain propylene glycol at aconcentration of from about 7% to about 10%, e.g., from about 5%, orfrom about 6%, or from about 7%, or from about 8% to about 9%, or toabout 10%, or to about 11%, or to about 12%. As the concentration ofpropylene glycol decreases, the ability of the salicylic acid to remaindissolved or suspended in the formulation diminishes, while as theconcentration of propylene glycol increases, the rheology of theformulation is undesirably reduced. An acne-combatting formulation mayalso contain a polyacrylic acid, e.g., Carbomer® (Lubrizol Corp.) havinga desired level of cross-linker, distance between cross-links,uniformity of cross-linking, degree of branching and the particle size,e.g., Carbomer Ultrez 30® which is a crosslinked polyacrylic acid. TheCarbomer® may be present in the formulation at a concentration of fromabout 0.5% to about 1.5%, e.g., from about 0.3%, or from about 0.4%, orfrom about 0.5%, or from about 0.6% and to about 2.0%, or to about 1.7%,or to about 1.5%, or to about 1.3%. As the concentration of Carbomer®increases, the rheology (viscosity) of the formulation increases, and asthe concentration of Carbomer® decreases, the rheology (viscosity) ofthe formulation decreases, so that a concentration of from about 0.5% toabout 1.5% provides a desirable viscosity. An acne-combattingformulation may also contain triethanol at a concentration of about 1.5%to about 3%, for example, from about 1.0%, or from about 1.2%, or fromabout 1.5%, or from about 1.7% to about 4%, or to about 3.5%, or toabout 3%, or to about 2.5%. As the amount of triethanolamine in theformulation decreases, the pH of the formulation becomes undesirably lowand also the viscosity of the formulation is undesirably reduced.Conversely, as the amount of the triethanolamine in the formulationincrease, the pH of the formulation becomes undesirably high and alsothe viscosity of the formulation is undesirably increased, so that aconcentration from about 1.5% to 3% provides a desired pH and viscosityfor the formulation. An acne-combatting formulation of the presentdisclosure may contain more than one, or all, of these listedcomponents, e.g., silver particles (including silver in the +2 oxidationstate) at a concentration of 10-32 ppm, salicylic acid at aconcentration of 0.5-2 wt %, propylene glycol at a concentration of 7-10wt %, Carbomer, e.g., Carbomer Ultrez 30 at a concentration of 0.5-1.5wt %, and triethanolamine at a concentration of 1.5-3 wt %.

The compositions of the present disclosure may contain a lubriciousagent or lubricant. When a composition of the present disclosurecontains a lubricious agent and that composition is applied topically,the composition will impart lubricity to the tissue to which it isapplied. For example, the composition may contain glycerin, which mayfunction as a lubricious agent. As another example, the composition maycontain a cellulose derivative, such as hydroxyethylcellulose (HEC) andcarboxymethyl cellulose. The lubricious composition of the presentdisclosure may contain a lubricious agent so as to create a personallubricant, where the personal lubricant may contain other components.See, for example, U.S. Pat. No. 6,114,398 (a composition for preventingand treating itching on a body part by reducing any of Candida species,Neisseria gonorrhoeae species, Peptostreptococcus lacrimalis species,Gardnerella vaginalis species present, the composition comprisingglycerin, a cellulose selected from the group of hydroxyethyl celluloseand carboxymethyl cellulose, glucono delta lactone, chlorine dioxide anda phosphate compound to retard escape of chlorine dioxide from thecomposition at a pH in the range of 6.0 to 7.4); U.S. Pat. No. 4,981,686(a personal lubricant composition, particularly a vaginal lubricant,having one or more of good lubricating ability, pleasant fragrance andtaste, greaselessness, nonstaining, water solubility, nonirritating,humectant and harmless if ingested; soothes vaginal tissue, does notprevent pregnancy and does not impede sperm motility); 2013/0251818 (apersonal lubricant containing royal jelly (see, e.g., U.S. Pat. No.5,871,754), a glow powder and xylitol), 2013/184233 (a skin lubricationlotion that functions as a skin rubbing anti-friction barrier compoundto prevent skin rashes from burning of skin from excessive rubbing, thelotion including one or more of a lubricant; a skin numbing ingredientsuch as lidocane; a vitamin ingredient, an ingredient that causes humanskin to tingle, sodium benzoate, potassium sorbate, citric acid,propylene glycol, xanthan gum, and guar gum), and 2009/0185995 as wellas PCT publication nos. WO 2014/055627 (a personal lubricant compositionthat includes at least one silicone-containing component, and ahydrophilic component comprising water and a polyol which provideadvantages such as to tactile and sensory feel); WO 2014/055621 (anon-irritating personal lubricant composition comprising a siliconefluid carrier and at least one sensorial agent, the composition having aviscosity of at least 175 centistokes); and WO 2009/016350 (a personallubricant composition comprising a vasodilator and at least one coolant,such as menthol or a cyclic carboxamide such (−) isopulegol).

As mentioned above, the present disclosure provides a personal lubricantcomprising silver particles, water and a thickening agent such ashydroxyethylcellulose (HEC). In preparing a personal lubricant, theformulation contains silver particles, such as silver particles with Ag+2 as mentioned elsewhere herein. In one embodiment, the silver ispresent at a concentration of at least about 1 ppm, or 5 ppm, or 8 ppm,or 10 ppm, or 12 ppm, or 15 ppm, and at a concentration of less thanabout 50 ppm, or 45 ppm, or 40 ppm, or 35 ppm, or 32 ppm, or 30 ppm, or25 ppm. For example, the formulation may contain between 10 ppm and 32ppm of silver particles. As the concentration of silver is decreased,the antimicrobial effectiveness of the silver undesirably decreases, andas the concentration of the silver is increased, the light sensitivityof the formulation undesirably increases, which leads to discolorationof the formulation to, e.g., a gray color. A personal lubricantformulation may also contain propylene glycol at a concentration of fromabout 2% to about 5%, e.g., from about 1%, or from about 2%, or fromabout 3%, to about 4%, or to about 5%, or to about 6%, or to about 7%.As the concentration of propylene glycol decreases, the lubricity of theformulation undesirably decreases, and as the concentration of propyleneglycol increases, the viscosity of the formulation undesirablydecreases, so that a concentration of about 2-5 wt % is a suitableconcentration. A personal lubricant formulation of the present inventionmay contain hydroxyethylcellulose (HEC) and/or hydroxypropylmethylcellulose (HPMC) as a thickening agent, at a concentration ofabout 1.25 wt % to about 2.5 wt %, e.g., from about 0.75 wt %, or fromabout 1.0 wt %, or from about 1.25 wt %, or from about 1.5 wt % to about2 wt %, or to about 2.25 wt %, or to about 2.5 wt %, or to about 2.75 wt%, or to about 3 wt %. As the concentration of thickening agentincreases, the viscosity of the personal lubricant increases, and as theconcentration of thickening agent decreases, the viscosity of thepersonal lubricant decreases, so that a concentration of about 1.25-2.5wt % is suitable. The personal lubricant may contain each of silver(e.g., in the +2 oxidation state) particles at a concentration of about10-32 ppm, thickening agent such as HEC or HPMC at a concentration of1.25-2.5 wt %, and propylene glycol at a concentration of about 2-5 wt%.

The compositions of the present disclosure may contain a natural plantextract, that is, an extract from flower, tree, root, or the like. Inone embodiment the extract is from aloe. Topical aloe has been reportedto inhibit infection and promote healing of minor burns and wounds,frostbite, as well as in skin affected by diseases such as psoriasis andseborrheic dermatitis. Other exemplary include ginger flower (see, e.g.,CN patent 103494737); sugar apple and rosemary extracts, optionally incombination with prickly ash extract (see, e.g., WO 2015/066352); anextract of tapirira guianensis (see, e.g., WO15036704); a polygonumbistorta extract (see, e.g., WO14155012 A1); an extract from a seed ofthe Nicotiana species (see, e.g., US2014356295); a silver ear extract(see, e.g., WO14191056 A1); an extract of water hyacinth (see, e.g.,EP2777709); an extract of zooplankton (see, e.g., WO14016086), anextract containing chicoric acid (see, e.g., EP2848286); or an extractthat contains riboflavin and/or salts or hydrates thereof (see, e.g.,WO15033316), to name a few.

The compositions of the present disclosure may contain one or more aminoacids. In one embodiment the amino acid is L-arginine, which is reportedto have anti-aging effects. See, e.g., Mohamed Z. Gad, Journal ofAdvanced Research, Volume 1, Issue 3, July 2010, Pages 169-177. In oneembodiment the amino acid is L-carnitine. In one embodiment the aminoacid is L-lysine. Other suitable amino acids include alanine,asparagine, aspartic acid, cysteine, cystine, glutamic acid, glutamine,glycine, histidine, isoleucine, leucine, methionine, phenylalanine,proline, serine, threonine, tryptophan, tyrosine and valine. Whenpresent, the amino acid, e.g., arginine, may be present in aconcentration of at least about 0.05 wt %, e.g., 0.06 wt %, or 0.7 wt %,or 0.8 wt %, or 0.9 wt %, or 1.0 wt %, in order to provide the desiredefficacy, e.g., the pH may be too low if too little amino acid is used.However, too much amino acid should be avoided, since silver can oxidizeamino acids and cause the release of ammonia, which leads to anundesirable rancid oil phase. In the formulations of the presentdisclosure, the amino acid concentration may be less than 0.5 wt %, orless than 0.4 wt %, or less than 0.3 wt %, or less than 0.2 wt %, orless than 0.1 wt % of the weight of the formulation. In one embodimentthe amino acid, e.g., L-arginine, is present in the formulation at aconcentration of between 0.08 wt % and 0.1 wt %.

The composition of the present disclosure may contain a dietarysupplement that imparts health benefits. For example, the compositionmay contain equol, also known as 4′,7-isoflavandiol. Other suitablesupplements include alpha lipoic acid, black cohosh, calcium, chromium,coenzyme Q10, DHEA, flaxseed, folic acid, ginko, glucosamine, melatonin,niacin, magnesium, probiotics, extract from red yeast rice, St. John'swort, vitamin c, vitamin D, vitamin E, SAM-e, saw palmetto, selenium,turmeric, valerian, whey protein, and yohimbe.

The composition of the present disclosure may contain a fragrance or anodor mask. Examples of fragrances and odor masks, include, withoutlimitation, menthol, anethole, carvone, eugenol, limonene, ocimene, n-20decylalcohol, citronellol, α-terpineol, methyl salicylate, methylacetate, citronellyl acetate, cineole, linalool, ethyl linalool,vanillin, thymol, spearmint oil, peppermint oil, lemon oil, orange oil,sage oil, rosemary oil, cinnamon oil, pimento oil, cinnamon leaf oil,perilla oil, wintergreen oil, clove oil, and eucalyptus oil.

In addition, the formulations, preparations, compositions and the likeas disclosed and/or claimed in the following patent documents mayincorporate colloidal silver particles as disclosed herein, to providecompositions of the present invention: WO14136993, WO15098433,WO15052804, WO15045167, WO14199936, WO14196602, WO14174868, WO14136886,WO14129240, WO13132878, WO14084099, WO14077334, WO14077189, WO14069173,WO14069400, WO14069403, WO14069388, WO14058048, WO14058060, WO14050487,US2015202137, US2014004210, WO13146891, WO13146797, WO13147012,WO13136890, WO13136616, WO13128736, US2014343169, WO13118836,US2014357721, WO13115099, US2014356401, US2014348765, WO13099378,US2014343170, US2015005396, US2014323591, WO13077072, US2015157546,US2014255323, WO13061712, US2014235732, US2014255527, WO13047204,WO13047196, WO13038861, WO13031327, US2013344013, US2014205552,US2014186281, US2014219939, US2014134255, WO12172622, US2014105840,US2014086864, WO12161215, WO12157694, WO12157587, US2014066358,WO12141255, WO12133825, WO12132603, US2014017191, US2014018444,WO12133293, US2014024724, WO12132951, WO12124436, WO12124766,US2014010901, WO12121309, US2013331468, WO12118055, WO12115247,US2013336908, WO12101741, WO12098765, WO12090297, WO12090581,WO12086579, WO12081446, WO12077639, WO12073928, WO12070309,US2013189335, WO12056959, US2013231401, US2014148516, WO12046500,WO12043614, US2013142853, WO12035904, US2013121939, and WO12017733. Eachof these patent documents is incorporated herein by reference.

The foregoing are exemplary of the components that may be present in anemulsion of the present invention. Particularly when the emulsion ispart of a cosmetic, dermatalogic or pharmaceutical composition, thecomposition may be contain additional ingredients that make thecomposition particularly well-suited for the intended use. For instance,one or more of antioxidants, anti-inflammatory agents, anti-acne agents,antimicrobial agents, collagen, chitosan, astringents, humectants,moisturizers, pH adjusters, skin bleaching/lightening agents, skinsoothing/healing agents and agents that help decrease the appearance ofsigns of aging may be incorporated into the emulsion of the presentdisclosure. Also, lightening agents, darkening agents such asself-tanning agents, shine control agents, anti-mycotic agents,anti-parasite agents, external analgesics, sunscreens, photoprotectors,depigmenting agents, keratolytic agents, detergents/surfactants,nutrients, vitamins, energy enhancers, anti-perspiration agents,deodorants, hair removers, firming agents, anti-callous agents, andagents for hair, nail, and/or skin conditioning may be included in thecompositions of the present disclosure. The composition may contain apigment (see, e.g., US2013266621).

The International Cosmetic Ingredient Dictionary and Handbook (15thEdition, 2014), published by the Cosmetic, Toiletries & FragranceAssociation, describes a wide variety of non-limiting cosmetic anddermatopharmaceutical ingredients commonly used in the skin careindustry, which are suitable for use in preparing emulsions havingcolloid silver particles as described herein. The disclosure of TheInternational Cosmetic Ingredient Dictionary and Handbook (15th Edition,2014), is incorporated by reference herein in its entireties for itsteachings of cosmetic and dermatopharmaceutical ingredients.

As stated above, the present invention provides emulsions whichincorporate colloidal silver, preferably in particulate form, and whichare particularly useful as cosmetic, dermatologic or therapeuticformulations, particularly in the form of creams, serums, lotions,ointments, and the like. However, in another aspect, the compositions ofthe present disclosure are not in emulsion form, and in fact may beoil-free, i.e., they do not contain any oil component. In suchcompositions, the silver is typically utilized as an aqueouscomposition, e.g., the silver particles are dispersed and suspended inwater, and such a composition can be used to provide the aqueouscomponent of formulation In addition to the colloidal silver, which hasbeen discussed above, the oil-free compositions may be prepared from theabove-listed ingredients, where the identified ingredients may not bethe exclusive ingredients that may be present in the formulation, butrather are options that may be employed in order to prepare the desiredserum, lotion, cream, ointment etc. that is oil-free.

For example, in one embodiment, the present disclosure provides anoil-free composition comprising colloidal silver particles that isuseful as a personal lubricant. In addition to water and colloidalsilver particles, the personal lubricant of the present disclosure willcontain a thickening agent such as hydroxyl ethyl cellulose (HEC). Thethickening agent is present in such an amount as to impart the desiredviscosity to the product. In one embodiment, the personal lubricantcontains 2% by weight of thickening agent such as HEC, however greateror less amounts of thickening agent may be incorporated into the productas needed to achieve the desired viscosity of the product. Otheringredients such as those identified above, may also be added to thepersonal lubricant.

As another example, in one embodiment the present disclosure provides anoil-free composition comprising colloidal silver particles that isuseful as an acne treatment medicament. In addition to colloidal silverparticles and water, the acne treatment composition of the presentdisclosure comprises an exfoliant. Exemplary exfoliants includesalicylic acid and glycolic acid. The acne treatment medicament mayfurther comprise optional ingredients such as an alcohol. Exemplaryalcohols include ethanol, propylene glycol and polyethylene glycol.

As another example, a formulation of the present disclosure may beformed from Silver Solution 20 ppm, and one or more of Caprylic/CapricTriglyceride, Octyldodecyl Myristate, Butylene Glycol, Tricaprylin,Ethylhexyl Stearate, Methyl Trimethicone, Peg-100 Stearate, Glycerin,Butyrospermum parkii (Shea Butter), Glyceryl Stearate, Cetearyl Alcohol,Polysorbate 60, Prunus armeniaca (Apricot) Kernel Oil, Ribes nigrum(Black Currant) Seed Oil, Citrus aurantium dulcis (Orange) Peel Oil,Rosa Damascena Flower Oil, Cinnamomum camphora (Camphor) Bark Oil,Linalool, Limonene, Camellia cinensis (White Tea) Leaf Extract, SodiumPca, Dimethicone, Sodium Hyaluronate, Sorbitol, Ethylhexylglycerin,Caprylyl Glycol, Hexylene Glycol, Carbomer, Sodium Dehydroacetate,Potassium Hydroxide, and Phenoxyethanol.

As another example, a formulation of the present disclosure may formedfrom Silver Solution 20 ppm, and one or more of Butyrospermum Parkii(Shea) Butter, Glycerin, Caprylic/Capric Triglyceride, Vitis vinifera(Grape) Seed Oil, Dicaprylyl Carbonate, Dimethicone, Prunus armeniaca(Apricot) Kernel Oil, Cetearyl Alcohol, Glyceryl Stearate, Cocosnucifera (Coconut) Oil, Prunus amygdalus dulcis (Sweet Almond) FruitExtract, Mel Extract/Honey Extract, Hydroxyethyl Acrylate/SodiumAcryloyldimethyl Taurate Copolymer, Tocopherol, Ethylhexylglycerin,Parfum/Fragrance, Xanthan Gum, Propylene Glycol, Sorbitan Isostearate,Polysorbate 60, Chlorphenesin, Peg-100 Stearate, Phenoxyethanol,Ceteareth-33, Benzyl Alcohol, Benzyl Benzoate, Hydroxyisohexyl3-Cyclohexene Carboxaldehyde, Linalool, Citronellol, ButylphenylMethylpropional, Coumarin, Hexyl Cinnamal, Limonene, and Geraniol.

The active components and ingredients as disclosed herein may beincorporated into a serum, lotion, cream or ointment of the presentdisclosure in an amount, or in amounts, that such components andingredients provide efficacy, as will be known to one of ordinary skillin the art.

Serums, Lotions, Creams and Ointments

The present disclosure provides colloidal silver particles in anemulsion, where the emulsion may be formulated as, for example, a healthcare product, beauty product or a pharmaceutical. The formulation maytake the form of a serum, a lotion, a cream or an ointment, as fourexamples. The formulation is typically intended for topicaladministration.

In general, body cream is heavier and contains a higher viscosity, orsticky mixture of water and oil compared to a lotion. Creams penetratethe skin and provide a barrier that prevents more moisture loss from theskin than lotion. Creams, however, tend to feel greasier. Apharmaceutical or dermatology cream is usually an even mixture of 50percent oil and 50 percent water. Creams are sometimes described as asemi-solid emulsion, half oil and half water. However, the ratio ofwater and oil in cosmetic cream and lotion varies and is also affectedby other ingredients, such as paraffin. Because body cream is thicker,it is usually sold in a tub or jar container. Creams are typically easyto use and are preferred by many people. They spread easily, absorbquickly and wash off with water. Overall, they have a medium viscosityor heaviness, and are reasonably hydrating without feeling too heavy onyour skin. Creams are always packaged in a tub or a tube; they are toothick to be dispensed in a pump. Creams are often used to treat acne inpatients whose skin is somewhat dry, as the creams promote hydration.Creams are also more beneficial in lighter skin, which in general ismore easily irritated than darker skin.

Body lotions are not as sticky and are more readily absorbed by the skinbecause they have a lower viscosity than body creams. This form ofmoisturizer usually has a higher water content, comes in a bottle andcan be poured out in a liquid form. Lotion is good for skin that is notexcessively dry or when it is preferable not to have a sticky, greasyfeeling on the skin. Lotions are thinner than creams, and are oftenpackaged in a pump. They absorb very quickly and feel very light on theskin. They are easier to distribute on hairy areas. Mostover-the-counter body moisturizers are lotions.

Ointments are more viscous that lotions or creams. They often containabout 80% oil and 20% water. These products feel greasy, they do notabsorb well into skin, and are generally not easy to use on large areas.They are ‘occlusive,’ which means they trap moisture and heat in verywell. Ointments promote medication absorption over all otherformulations. If an ingredient is in an ointment, it is always morepotent than the exact same ingredient packaged in a cream or lotion. Forexample, amcinonide is a topical steroid. In an ointment it isconsidered high potency, and in a cream or lotion it is consideredmedium-high potency.

The formulation may be a serum. Serums are the newer cousin of creamsand lotions and are currently very much in vogue in the cosmeticsindustry. Serums tend to be thick liquids and are usually (but notalways) clear. They may be water based which makes them lightweight andquickly absorbed into the skin. Serums are light, fast-absorbing liquidsused as an alternative or in addition to creams or lotions. The biggestdifference between a serum and a cream or lotion is what the formulationdoesn't include. Serums leave out occlusive, or airtight, moisturizingingredients such as petrolatum or mineral oil that keep water fromevaporating. They also contain fewer lubricating and thickening agents,like nut or seed oils. A serum often has a high concentration of activeingredients, including anti-aging ingredients such as antioxidants,peptides and skin brighteners such as kojic acid.

Many companies formulate serums for the delivery of topical activeingredients such as Vitamin C, equol, isoflavandiol, peptides, alphahydroxy acids or retinols. For example, an exemplary serum of thepresent disclosure contains a high concentration alpha hydroxyformulation for hyperpigmentation and scars. Another serum of thepresent disclosure contains vitamin K and retinol to help to reduce theappearance of dark circles and fine lines. Another serum of the presentdisclosure contains 5% Vitamin C to help boost collagen production andeven skin tone. Another serum of the present disclosure contains vitaminC and madecassoside to boost collagen production and even skin tone. Yetanother serum of the present disclosure contains 5% matrixyl (a peptide)which boosts collagen production in order to reduce the appearance ofwrinkles. Serums provide a concentrated way to get anti-agingingredients into the skin and can be layered under other productswithout interfering with them. Because serums tend to be light and waterbased, most skin types can use them. Thus, the present disclosureprovides anti-aging serums which are serums that include both anti-agingcomponents and colloidal silver as disclosed herein.

Accordingly, in one embodiment the present disclosure includes colloidalsilver incorporated into a serum, or in other words, a serum comprisingcolloidal silver as disclosed herein. The serum may or may not includean oil phase. If it does not contain an oil phase, then the formulationwill not be an oil-in-water or water-in-oil emulsion as disclosedherein. Accordingly, in one embodiment, the present disclosure providesa serum that does not contain an emulsion, but does not colloidalsilver. In another embodiment, the present disclosure provides a serumthat does contain an emulsion and also contains colloidal silver. Thus,the serum may contain an oil-in-water emulsion, optionally a diluteoil-in-water emulsion which contains primarily water on a weight basis.

In summary, both creams and lotions are emulsions having a water and oilphase. The salient difference is the thickness. Lotions are alow-viscosity emulsion. Most lotions are oil in water emulsions butwater in oil lotions also are formulated. Lotions are designed to beapplied without heavy rubbing. Since they have a low viscosity, theyusually are easily rubbed onto the skin. On the other hand, creams aremuch higher viscosity materials. They generally are semi-solidemulsions. Like lotions, creams can be either oil-in-water orwater-in-oil emulsions. Oil-in-water creams are more comfortable andcosmetically acceptable as they are less greasy and more easily washedoff using water. Water-in-oil creams are more difficult to handle butare more moisturizing as they provide an oily barrier that reduces waterloss from the skin. Serums may or may not contain an emulsion, buttypically contain primarily water as the carrier, and lesser amounts ofoils than are typically found in a lotion, cream or ointment.

In one embodiment, the emulsions of the present invention are notincorporated into a gel. Gels typically have an alcohol base, and in oneembodiment the formulations of the present disclosure do not include analcohol base. In various embodiments, the formulations of the presentdisclosure do not include any alcohols having less than 8 carbon atoms,or less than 7 carbon atoms, or less than 6 carbon atoms, or less than 5carbon atoms, or less than 4 carbon atoms, or less than 3 carbon atoms.In other embodiments, the formulations of the present disclosure mayinclude alcohol, but only at low concentrations, e.g., less than 10%, orless than 8%, or less than 6%, or less than 5%, or less than 4%, or lessthan 3%, or less than 2%, or less than 1% of the overall weight of theformulation, where alcohols have less than 8 carbon atoms, or less than7 carbon atoms, or less than 6 carbon atoms, or less than 5 carbonatoms, or less than 4 carbon atoms, or less than 3 carbon atoms. In eachof the compositions and formulations described herein, in one embodimentthe composition and formulation is free of volatile alcohol, whichrefers to alcohols have 1 or 2 or 3 or 4 or 5 carbon atoms. In each ofthe compositions and formulations described herein, in one embodimentthe composition and formulation is alcohol free. In each of thecompositions and formulations described herein, in one embodiment thecomposition and formulation is substantially alcohol free, which refersto a composition or formulation that contains less than 5 wt % of analcohol having less than 6 carbons atoms.

Manufacturing Process

In one embodiment, the present disclosure provides methods of making anemulsion that contains colloidal silver. For example, the emulsion maybe made from an oil phase and a water phase, where the water phasecontains colloidal silver. At elevated temperature and with vigorousstirring, the oil phase may be gradually added to the water phase, orthe water phase may be gradually added to the oil phase. An emulsifyingwax or like agent should be present in order to stabilize the emulsiondroplets. In various embodiments, the temperature at which the emulsionis prepared is within the range of 40° C. to 65° C., or within the rangeof 45° C. to 60° C., or within the range of 49° C. to 57° C., or withinthe range of 50° C. to 55° C. When the temperature is too low, one ormore components of the formulation may precipitate from the formulationand/or the emulsion particle size is poor, while when the temperature istoo high, the formulation may undergo an undesirable change in color.The emulsion formulations of the present disclosure may be prepared bycombining oil and water phases at a temperature of less than 70° C., orless than 65° C., or less than 60° C., in order to avoid unwanteddiscoloration.

Depending on the exact formulation, the product may have the form of alotion, cream, ointment, etc. As mentioned previously, a lotion isgenerally less viscous (less thick) than a cream, and a cream isgenerally less viscous (less thick) than an ointment. In one embodiment,the formulation of the present disclosure is a lotion. In anotherembodiment, the formulation of the present disclosure is a cream. Inanother embodiment, the formulation of the present invention is anointment. In another embodiment, the formulation of the presentinvention is a serum. In another embodiment, the formulation of thepresent disclosure is not a gel.

For example, to prepare a lotion, about 75-85 parts, or about 80 parts(parts refer to grams for every 100 grams of final formulation) of ABLsolution (an aqueous dispersion of silver particles from ABLManufacturing LLC) is combined with about 5-10 parts, or about 6-8parts, or about 7 parts of emulsifying wax, and about 5-10 parts orabout 6-8 parts or about 7 parts of an oil such as coconut oil, andabout 3-7 parts, or about 4-6 parts, or about 5 parts of fatty acid suchas stearic acid, and about 0.1-1 parts, or about 0.3-0.8 parts, or about0.5 parts of a vitamin such as vitamin E, and a pH controlling agent asneeded, for example, about 0.1-0.5 parts, or about 0.2-0.4 parts, orabout 0.25 parts triethanolamine. To prepare a lotion comprising anoil-in-water emulsion, a heated oil phase comprising emulsifying wax,fatty acid, oil and vitamin are gradually added to a vigorously stirringaqueous phase comprising ABL solution and hyaluronic acid.

As another example, to prepare a cream, about 60-75 parts, or about65-70 parts, or about 67.5 parts (parts refer to grams for every 100grams of final formulation) of ABL solution (an aqueous dispersion ofsilver particles from ABL Manufacturing LLC) is combined with about 7-15parts, or about 8-12 parts, or about 10 parts of emulsifying wax, andabout 8-16 parts or about 10-14 parts or about 12 parts of an oil suchas coconut oil, and about 4-12 parts, or about 6-10 parts, or about 8parts of fatty acid such as stearic acid, and about 0.5-2 parts, orabout 1 part of a vitamin such as vitamin E, and a pH controlling agentas needed, for example, about 0.1-1 parts, or about 0.2-0.8 parts, orabout 0.5 parts triethanolamine. To prepare a cream comprising anoil-in-water emulsion, a heated oil phase comprising emulsifying wax,fatty acid, oil and vitamin are gradually added to a vigorously stirringaqueous phase comprising ABL solution and hyaluronic acid.

Emulsions containing silver particles may be prepared in analogy to themethods disclosed in the references identified herein, but using anaqueous colloidal silver in lieu or, or in addition to, the aqueousphase disclosed in those references.

In various embodiments, the aqueous particulate silver compositions usedto prepare the compositions of the present disclosure have silverparticles at a concentration of 5-50 ppm, or at 10-40 ppm, or at 15-30ppm, or at 20-25 ppm (parts per million) in the water.

In various embodiments, the present disclosure provides colloidal silverparticles as disclosed herein may be incorporated into the formulations,preparations, compositions and the like that are disclosed in thefollowing PCT and US patent documents. For example, as appropriate, thepresent invention provides that an aqueous dispersion of colloidalsilver particles as disclosed herein may be used in lieu of some or allof the aqueous component(s) in any of the formulations described and/orclaimed in the following publications. Each of these publications isincorporated herein by reference: WO14136993 directed to a skin carecosmetic having an antipollution property that can protect the skin froma variety of external irritants including UV rays as well as atmosphericpollutants and acidic liquids. WO15098433 directed to an oil-in-wateremulsified sunscreen cosmetic. WO15052804 directed to formulations thatcontain a low-stringiness thickener such as a polyacrylic acid or a saltthereof. WO15045167 directed to a cosmetic that has excellent glossinessdirectly after application, which does not exhibit shininess even whensebum emerges with the passage of time, and that causes pores to be lessnoticeable. This cosmetic is characterized by comprising coatedparticles (a) in which a flaky substrate powder surface is coated withsilicone elastomer particles or silicone elastomer/silicone resincomposite particles and an oil component (b) that contains a volatilesilicone oil; and by the refraction index of the oil component as awhole being 1.39-1.43. WO14199936 directed to a hair treatmentcomposition that can effectively remove polyvalent metal ions such ascalcium ion without using any chelating agent, where the hair treatmentcomposition contains a microemulsion of amodimethicone. WO14196602directed to a fragrance-containing capsule having a core substancecomprising a specified fragrance and a wall material formed from one ormore polymers selected from poly(alkyl(meth)acrylates) and polystyrene.WO14174868 directed to an aqueous composition in which a vehicle anddrops of oil are present together in stable fashion, and personal careproducts formed therefrom. WO14171238 directed to a cleansingcomposition for a pump foamer, having good foam qualities and excellentlow-temperature stability, comprising (a) 2-5 mass percent of ionicsurfactant(s), and (b) 20-60 mass percent of polyhydric alcoholscontaining propylene glycol, characterized in that: in the ionicsurfactant(s) (a), the content of higher fatty acid soap(s) having 5 to25 carbon atoms amounts to 90 mass percent or more; and the amount ofpropylene glycol contained in the polyhydric alcohols (b) is less than20 mass percent relative to the whole composition. WO14136886 directedto a water-in-oil emulsion cosmetic composition which is capable ofremaining stable even in cases where a polar oil is blended therein,having 0.1-2 percent by mass of an organic modified clay mineral; 0.1-2percent by mass of a hydrophobic silica; 2-5 percent by mass of asilicone surfactant; an oil component wherein 10-50 percent by mass ofthe total oil component is a non-polar hydrocarbon oil; and 20-60percent by mass of an aqueous phase component. WO14129240 directed to anemulsion-type eyelash cosmetic (mascara) which can minimize the cloggingof a comb without lowering the curling power, characterized bycontaining (a) 20 to 30 mass percent of an alkyl acrylate copolymeremulsion, (b) 3 to 6 mass percent of a moisturizing agent and (c) 0.1 to0.4 mass percent of a polyacrylic acid salt. WO13132878 directed to anoil-in-water emulsion composition that is high in the moisturizingeffect, characterized by comprising (a) hyaluronic acid or a saltthereof, (b) ammonium acryloyldimethyltaurate/beheneth-25 methacrylatecrosspolymer, (c) water-holding oil, (d) glycerin, and (e) ethanol.WO14084099 directed to an external preparation for the skin, which ischaracterized by containing silver-supported tricalcium phosphate, alumand zinc oxide, where silver-supported tricalcium phosphate serves as adeodorant and alum serves as an antiperspirant, the preparation furthercontaining colloidal silver particles as disclosed herein. WO14077334directed to formulations that contain phenyl ethyl cinnamate, whichinhibits excessive melanin production in the skin, and a whitening agentcomprising the same. WO14077189 directed to a water-in-oil emulsionsunscreen cosmetic that has a strong ultraviolet protection effect,characterized by containing hydrophobicized silica-coated zinc oxidemicroparticles, a volatile hydrocarbon oil, and volatile dimethicone;and the sum of the volatile hydrocarbon oil and volatile dimethiconebeing 3-45 mass percent relative to the total amount of the sunscreencosmetic. WO14069173 directed to a sunscreen cosmetic characterized bycomprising an ultraviolet-ray-blocking agent; a volatile oily material;cetyl dimethicone copolyol; an (acrylate/stearyl acrylate/dimethiconemethacrylate) copolymer; and an organic modified clay mineral.WO14069400 directed to an organosiloxane derivative composition whichcan cause the stable gelification of small amounts of oils, and whichmay be used in personal care products. WO14069403 directed to awater-in-oil emulsion composition characterised by comprising 1-20 masspercent of a polyhydric alcohol fatty acid ester and/or a hydrocarbon;3-20 mass percent of a transparent non-volatile silicone oil; 0.1-5 masspercent of decyl trisiloxane carboxylic acid zinc, and water, useful inthe preparation of personal care products. WO14069388 directed to a hairconditioner composition comprising (a) a cationic surfactant, (b) ahigher alcohol, (c) an aromatic acid, (d) a high polymer amino-modifiedsilicone, (e) octyl palmitate or a hydrocarbon oil having a meltingpoint of 35 to 53 degrees C., and (f) water. WO14058048 directed to amakeup base cosmetic for skin which comprises a water-containing aqueousphase as a continuous phase and contains a vinyl acetate polymer, apolyhydric alcohol, and a hydrophilic non-ionic surfactant, where thevinyl acetate polymer is present at a ratio of 0.5-7 mass percentrelative to the total weight of the cosmetic and dispersed as particlesin the aqueous phase; the amount of the polyhydric alcohol is 0.5-5.5parts by mass per part by mass of the vinyl acetate polymer; and thehydrophilic non-ionic surfactant is present at a ratio of 1-5 masspercent relative to the total weight of the cosmetic. WO14058060directed to cosmetic formulations used in a method including applying acosmetic material to skin, a step for pasting the base material filmsurface of a thin film to skin, and a step for eliminating the supportbody of the pasted thin film, and is characterized by the thin filmcomprising a support body and a base material film having a thickness of10-500 nm. WO14050487 directed to a liquid antiperspirant compositionhaving an excellent sensation of coolness and excellent stability,comprising menthol or a derivative thereof; a di-long-chain-typecationic surfactant; zinc paraphenolsulfonate; ethanol; and a claymineral. US2015202137 directed to a water-in-oil emulsion cosmeticcomprising 0.5 to 10 mass percent of a sterol derivative, a volatile oilhaving low compatibility with the sterol derivative, an emulsifyingagent, and 60 to 90 mass percent of an aqueous component. US2014004210directed to formulations comprising rosemary extract having ahyaluronidase inhibitory activity, and retinol acetate, which canenhance the hyaluronidase inhibitory activity of rosemary extract.WO13146891 directed to formulations that comprise a subcutaneous fataccumulation inhibitor which comprises at least one component selectedfrom the group consisting of a pine extract, a saffron extract, acinchona extract and a comfrey extract. WO13146797 directed topreparations that have heparan sulfate production promotion ability andcomprise a mixture of an extract of the Madonna lily (Lilium candidum)and glucosamine. WO13147012 directed to compositions that includetitanium oxide particles which are each composed of rod-shaped titaniumoxide primary particles that are gathered into a three-dimensionallyradial form and which have particle diameters of 0.5 to 50 mum.WO13136890 directed to an external preparation for the skin comprisingsilver-supporting antibacterial tricalcium phosphate and a polypropyleneglycol having a number average molecular weight of 700-4,000, acopolymer of a polypropylene glycol having a number average molecularweight of 700-4,000 and a polybutylene glycol, or a derivative of apolypropylene glycol having a number average molecular weight of700-4,000. WO13136616 directed to a water-in-oil emulsion compositionwhich contains 70-98 percent by mass of an aqueous component, with theaverage emulsion particle diameter of the internal water phase being10-100 mum, and further comprising3,7,11,15-tetramethyl-1,2,3-hexadecane triol, diglyceryl diisostearate,a polyoxyethylene-methyl polysiloxane copolymer, an aqueous component,and an oil component. WO13128736 directed to a composition which can beused daily, for inhibiting deterioration in skin condition, thecomposition containing one or more types of compounds selected fromD-methionine, and a derivative and/or a salt thereof, and where thecomposition may be an external skin preparation, a cosmetic, a wrinkleinhibitor, or a drug for skin diseases. US2014343169 directed to anoil-in-water emulsified skin cosmetic comprising acetylated hyaluronicacid, a specific polymethacryloyloxyethyl phosphorylcholine derivative,non-emulsifying cross-linked silicone, glycerin, polyvinyl alcohol, anacrylamide type thickener, and an oil component. WO13118836 directed toan oil-in-water-type emulsion skin cleanser which has high cleansingperformance, which comprises (a) 45 to 70 mass percent of an oilycomponent, (b) 10 to 30 mass percent of a polyoxyethylene monofatty acidglyceryl having an HLB value of 8 to 14, (c) 10 to 45 mass percent ofwater and (d) 0.01 to 1 mass percent of a thickening agent and has theform of an emulsion or a cream. US2014357721 directed to a redispersiblepowder-dispersed cosmetic which has a clear supernatant when unused,comprising (A) succinic acid and/or a salt thereof, (B) bentonite and(C) a hydrophilic surfactant. WO13115099 directed to a water-in-oilemulsion makeup cosmetic comprising (A) 0.1 to 10 mass percent of acarboxylic acid-modified silicone having a molecular weight of 800 orlower and including a specific structure, (B) 0.1 to 20 mass percent ofa non-volatile oil, (C) 1 to 50 mass percent of a volatile oil, and (D)2 to 95 mass percent of a powder component. US2014356401 directed to aliquid cosmetic which minimizes stickiness or stiffness caused by theincorporation of a large amount of a moisturizing agent and comprising10-40 percent by mass of a moisturizing agent, 0.01 to 3 percent by massof an oil, 0.01-5 percent by mass of a hydrophilic surfactant, and0.001-0.3 percent by mass polyacrylic acid or a metal salt thereof.US2014348765 directed to a water-in-oil emulsified skin cosmeticcomprising water at 5-50 wt percent, ethanol at 1-20 wt percent,volatile oil at 2-50 wt percent, and a carboxy decyl trisiloxane at0.1-5 wt percent. WO13099378 directed to an extract from the plantPeucedanum japonicum Thunb. and having collagen production promotingaction, and cosmetic formulations that contain this extract.US2014343170 directed to a corona-core microgel emulsifying agentcomposed of a copolymer obtained by polymerizing polyethylene oxidemacromonomers, hydrophobic monomers, and cross-linking monomers underspecific conditions as well as an oil-in-water emulsified compositionusing the emulsifying agent for emulsification, and cosmeticformulations containing the agent. US2015005396 directed to anoil-in-water emulsion composition which is characterized by containing(A) a non-emulsifying cross-linked polymethyl siloxane, which contains(a1) a dimethicone crosspolymer and (a2) a non-emulsifying cross-linkedpolymethyl siloxane other than a dimethicone crosspolymer; (B) anassociative thickener; (C) a polyether-modified silicone; (D) a siliconeoil; and (E) water. US2014323591 directed to a water-based skin cosmeticcomprising a thickener composed of microgel obtained by using acomposition that has an organic solvent or oil component as thedispersion medium and water as the dispersion phase, dissolving a watersoluble ethylenically unsaturated monomer in the dispersion phase, andradically polymerizing it in the dispersion phase, wherein the microgelis obtained by radically polymerizing dimethylacrylamide and2-acrylamido-2 methylpropane sulfonic acid under the conditions in whicha single phase microemulsion or fine W/O emulsion is formed by using asurfactant. WO13077072 directed to an oxidation hair dye which comprisesa first agent containing an alkaline agent and a second agent containingan oxidizing agent, said first and second agents characterized by,immediately after mixing the first agent with the second agent providesa composition containing a bicontinuous microemulsion phase or alamellar liquid crystal phase. US2015157546 directed to an oil-in-watertype emulsified sunscreen cosmetic which contains (a) 0.1 to 5.0 masspercent of an organosiloxane derivative, (b) 0.1 to 5.0 mass percent ofpoly(ethylene glycol) stearate, (c) 10.0 to 25.0 mass percent of anultraviolet radiation absorber and (d) a higher alcohol. US2014255323directed to an organic UV absorber-free, oil-in-water emulsion sunscreencosmetic that includes: (A) zinc oxide and/or titanium dioxidehydrophobized with octyltriethoxysilane and/or dimethylpolysiloxane; (B)a liquid higher fatty acid; (C) a silicone or a sugar ester of astructure containing a carboxyl group; (D) a non-ionic surfactant; (E)sodium carboxymethyl cellulose; and (F) water. WO13061712 directed to anO/W emulsion composition having fine emulsion particle diameters that isprovided by a method using a higher aliphatic alcohol and an anionicsurfactant that forms an alpha-gel in water. US2014235732 directed to anoil-in-water emulsion cosmetic comprising: (A) 0.1-5 mass percent ofhydrogenated polyisobutene with a number average molecular weight of2000 to 3000, (B) 0.1 to less than 1 mass percent of higher alcohol, (C)1 to 25 mass percent of an oil component, (D) 0.3-5 mass percent ofsurfactant, (E) 0.05 to 5 mass percent of water-soluble thickener, and(F) an aqueous component, wherein the blending quantity of nonpolar oilis 30 percent or lower of the total amount of component (C).US2014255527 directed to a skin care composition comprising at least oneof lavender oil and eucalyptus oil, in addition to an alkylene oxidederivative. WO13047204 directed to a translucent oil-in-water emulsioncosmetic containing 0.01-1 mass percent of a di-long chain cationicsurfactant (A), 0.01-2 mass percent of a non-ionic surfactant (B) havinga sterol backbone with an HLB of 10-18, 0.01-1 mass percent of an oil(C) that is liquid at room temperature, 0.1-10 mass percent of aspecific alkylene oxide derivative (D) (for example, POE(14) POP(7)dimethyl ether or the like), 0.1-20 mass percent of a C1-3 monohydriclower alcohol (E), and water (F), [component (C)/component (A)+component(B)]=0.60 or lower (mass ratio). The translucent oil-in-water emulsioncosmetic may also contain menthol and/or camphor. WO13047196 directed toa formulation for improving silicone elastomer dispersibility(stability), which can be applied to a broad range of oil-in-wateremulsion bases, comprising (a) a water-soluble thickener having ahydrophobic group; (b) a non-ionic surfactant having an HLB of 14 orhigher; (c) a polyether modified silicone having an HLB of 3-5; and (d)a non-emulsifying crosslinked silicone. WO13038861 directed to atransparent to semi-transparent liquid cosmetic material which contains(a) 0.01 to 3 mass percent of an oil component and (b) a hydrophilicsurfactant selected from among a polyoxyethylene hardened castor oil anda polyoxyethylene phytosterol and which has an L value of 60 or higher,wherein isostearyl alcohol accounts for 60 mass percent or more of theoil component (a), and optionally (c) a lipophilic surfactant selectedfrom among polyglyceryl diisostearate, sorbitan sesquiisostearate andsorbitan sesquioleate. WO13031327 directed to an oil-in-water emulsioncosmetic material for skin which comprises glyceryl tricaprylate,monostearic acid polyethylene glycol adduct, a microgel and water.US2013344013 directed to a water-in-oil emulsified sunscreen cosmeticcomprising ultraviolet absorbent, silicone backbone powder, methylpolymethacrylate powder, hydrophobicized platelike powder, surfactant,oil and water. US2014205552 directed to a water-in-oil emulsifiedsunscreen cosmetic characteristically comprising hydrophobicized zincoxide and/or hydrophobicized titanium dioxide, lipophilic nonionicsurfactant, one or more components selected fromdi(phytosteryl/2-octyldodecyl)N-lauroyl-L-glutamate phytosterylmacadamiate and cholesteryl macadamiate, volatile silicone oil and/orhydrocarbon oil, and water. US2014186281 directed to a water-in-oil-typeskin-whitening cosmetic comprising an alkoxysalicylic acid or a saltthereof, an organic modified clay mineral, and a liquid fatty acid.US2014219939 directed to a liquid skin-conditioning compositioncomprising tranexarnic acid and derivatives thereof andcarboxymethylcellulose as a thickener. US2014134255 directed to anoil-in-water emulsion cosmetic having excellent in emulsion stability,comprising (a) to (d): (a) one or more amphipathic substances selectedfrom (a1) to (a3): (a1) an amphipathic protein, (a2) a copolymer of2-acrylamido-2methylpropane sulfonic acid or a salt thereof andvinylpyrrolidone, (a3) a microgel, (b) particles with the averageparticle size of less than 500 nm, (c) an oil component, and (d) anaqueous component. WO13008595 directed to an oil-in-water-type externalpreparation for the skin, comprising (a) a high-molecular-weightpolyethylene glycol, (b) a higher alcohol, (c) sodiumN-stearoyl-N-methyltaurine in an amount of less than 2.0 mass percent,and (d) a nonionic surfactant. WO12172622 directed to a solidwater-in-oil-type emulsion cosmetic comprising a volatile lineardimethylsilicone tetramer, a volatile linear dimethylsilicone pentamer,a solid wax and/or an oil-gelling agent, water, a lipophilic surfactantand a powder. US2014105840 directed to a solid cosmetic for lipscomprising (a) 5 to 30 mass percent of hydrogenated polyisobutene, (b)30 to 70 mass percent of one or more kinds of methyl phenyl siliconesthat separate from (a) when mixed therewith at 25 degrees centigrade,(c) 0.5 to 15 mass percent of oil that separates from both (a) and (b)when mixed therewith at 25 degrees centigrade, and (d) 4 to 12 masspercent of wax. US2014086864 directed to a shampoo compositioncomprising: (i) an anionic surfactant which is a taurine-derivativesurfactant; (ii) an amphoteric surfactant which is an alkylamide betainesurfactant; (iii) a cationic conditioning polymer; and (iv) 0.01 to 1mass percent of a quaternary ammonium group-containing silylatedurethane polymer. WO12161215 directed to a conditioner compositioncontaining a (i) cationic surfactant, (ii) a higher fatty alcohol, and(iii) 0.01-1 percent by mass of a quaternary-ammonium-group-containingsilylated urethane polymer and further characterized in that thecationic surfactant (i) comprises the following: (a) an imidazolinequaternary ammonium salt having a specific structure or along-chain-dialkyl quaternary ammonium salt having a specific structure;and (b) a long-chain-monoalkyl quaternary ammonium salt having aspecific structure. WO12157694 directed to an oil-in-water-type emulsioncosmetic comprising an aqueous phase, an oily phase dispersed in theaqueous phase, and a powder dispersed in the oily phase, and ischaracterized in that the oily phase contains a silicone oil, a volatilehydrocarbon oil, an organic ultraviolet ray absorber, and aside-chain-type amino-modified silicone. WO12157587 directed to ananti-wrinkle composition comprising a matrix metalloproteinase (MMP)inhibitor and/or laminin 5 production promoter, as well as ananti-wrinkle agent, each of which comprises 1-piperidine propionateand/or a salt thereof. US2014066358 directed to a translucent fragrancecomposition containing a large amount of perfume, comprising (a)silicone oil and (b) alpha-olefin oligomer that is a hydrogenatedtrimer, tetramer, pentamer, and/or hexamer of alpha-olefin having 4 to12 carbon atoms, (c) polyether-modified silicone, (d) perfume which is 3to 30 percent by mass in the composition; (e) lower alcohol having 1 to4 carbon atoms and (f) water. WO12141255 directed to a skin lighteningcomposition comprising chafuloside B. WO12133825 directed to a hot flashsuppressant composition which contains apelin or an apelin receptoragonist; and further comprising at least one of Rubus buergeri,Kalimeris yomena, Stauntonia hexaphylla, Rubus grayanus, Kalimerisindica, Pasania edulis, Merica rubra, Syzygium jambos, Quercus serrataand extracts of these plants, as well as a saffron extract, a pineextract, a cinchona extract, a comfrey extract, a Scutellaria extract, arosemary extract, an apricot seed powder, a gentian extract, a thymeextract, a mint powder, a Zizyphi fructus extract, a hop extract, akiwifruit extract, a roman chamomile extract, an apple extract, ahawthorn extract and a turmeric extract. WO12132603 directed to a skincare composition comprising (A) a silver ion-supporting antibacterialzeolite and (B) one of a polypropylene glycol having a number-averagemolecular weight of 700-4,000, a copolymer of a polypropylene glycol anda polybutylene glycol, and a derivative of a polypropylene glycol.US2014017191 directed to a water-in-oil emulsion cosmetic that isexcellent in the resilient and supple (in other words, firm andtensional) comprising the following (A) to (D): (A) 0.5 to 10 masspercent of hydrogenated polyisobutene (B) an oil containing (b1) (b1) avolatile oil of low compatibility with (A) (C) an emulsifying agent and(D) 60 to 90 mass percent of an aqueous component, wherein thepercentage of component (b1) is 45 to 85 percent with respect tocomponent (A) and component (B). US2014018444 directed to a water-in-oilemulsion cosmetic comprising the following (A) to (D): (A) 0.5 to 10mass percent of bis-diglyceryl polyacyladipate-2 (B) an oil containing(b1) (b1) a volatile oil of low compatibility with (A) (C) anemulsifying agent and (D) 60 to 90 mass percent of an aqueous component,wherein the percentage of component (b1) is 40 to 85 percent withrespect to component (A) and component (B). WO12133293 directed to aneyelash cosmetic comprising (a) 0.1 to 35 mass percent of a dextrin(palmitic acid/2-ethylhexanoic acid) ester, (b) 1 to 13 mass percent ofa sucrose fatty acid ester, (c) 0.1 to 10 mass percent of a non-ionicsurfactant and (d) 0.1 to 13 mass percent oftri(trimethylsiloxy)silylpropylcarbamic acid-pullulan. US2014024724directed to a film-shaped external preparation comprising awater-soluble cellulose derivative such as hydroxypropyl methylcelluloseas a primary component of the film; and also containing hydroxyethylurea. WO12132951 directed to a cosmetic material for sunscreencomprising (a) an aqueous dispersion of an oil-soluble ultraviolet rayabsorber and (b) agar microgel, and optionally containingbis-ethylhexyloxyphenol methoxyphenyl triazine and an organic polymer,methylene bis-benzotriazolyl tetramethylbutylphenol and nonvolatiledimethicone. WO12124436 directed to a skin cosmetic which has anexcellent whitening effect and an excellent wrinkle ameliorating effectcomprising: (a) one or more kinds of a pyrimidyl pyrazole compounds; and(b) one or more non-emulsifying crosslinked silicone. WO12124766directed to a concentrated liquid hair cleaning composition comprising0.1-5 mass percent of a cationic polymer, 40-60 mass percent of ananionic surfactant, and water. US2014010901 directed to a bleomycinhydrolase production promoter composition comprising one or a pluralityof ingredients selected from the group consisting of chestnut roseextract, angelica root extract, cork tree bark extract, Lamium albumextract, rosemary extract, benzenesulfonyl GABA and erythritol.WO12121309 directed to an oil-based solid cosmetic comprising (a) asolid oil component (a microcrystalline wax, a paraffin wax, etc.) in anamount of 2 to 10 percent by mass, (b) an organic modified clay mineralin an amount of 2.5 to 8 percent by mass, (c) a specificpolyglycerol-modified silicone (for example, bis-butyldimethiconepolyglyceryl-3, etc.) in an amount of 0.3 to 8 percent by mass, (d) acationic surfactant in an amount of 0.1 to 2 percent by mass, and (e) abranched saturated fatty acid having 14 to 24 carbon atoms in an amountof 0.2 to 7 percent by mass. US2013331468 directed to oil in wateremulsions prepared by a process comprising emulsifying, at a temperatureof 70 degrees centigrade or higher, an oil phase comprising (A) amono-branched fatty acid POE (0-60) glycerin ester, (B) a linear higheralcohol having 16 or more carbon atoms capable to form an alpha-gel inwater with said (A), and (C) an oil component, and a part of an aqueousphase (a first aqueous phase) comprising (D) water; and the cooling ofthis emulsified part by mixing with the remaining main aqueous phase (asecond aqueous phase) at 10 to 35 degrees centigrade, wherein an aqueoussolvent in the emulsified part is 15 mass percent or less. WO12118055directed to a transparent or translucent oil-in-water emulsifiedcosmetic containing, (A) 0.1 to 2 mass percent of a di-long-chaincationic surfactant, (B) 0.1 to 2 mass percent of a non-ionic surfactantwith an HLB of 10 to 18, (C) 0.01 to 2 mass percent of an oil that isliquid at room temperature (25° C.), (D) 1 to 20 mass percent of aglycol, and (E) water. WO12115247 directed to a stratum corneum peelingaccelerator composition comprising a mesotrypsin expression enhancerselected from the group consisting of Gingko biloba extract, Saxifragastolonifera extract, Rosa roxburghii extract, dipotassium glycyrrhizate,and ectoine. US2013336908 directed to an oil-in-water sunscreen cosmeticcomposition comprising: (a) an aqueous dispersion of an oil-solubleultraviolet absorbent; (b) one or two or more of crosslinkedpolyether-modified silicones and crosslinked alkyl polyether-modifiedsilicones; (c) a low-viscosity silicone oil; and (d) water, optionallywith methylene bisbenzotriazolyl tetramethylbutylphenol. WO12101741directed to compositions containing a tie-2 activator comprising theextracts of the stem branch or seed of sokakushi (Gleditsia sinensisLam.), polygonatum rhizome (Polygonatum sibiricum Red.), AngularSolomon's Seal (Polygonatum officinalle), the fruit or seed oftrichosanthes (Trichosanthes kirilowii Maxim), and/or Indian Mulberry(Morinda officinalis How.). WO12098765 directed to a makeup cosmeticproduced by mixing (A) a hydrophobization coloring material and (B)metallic soap-treated titanium oxide microparticles. WO12090297 directedto a sunscreen cosmetic characterized in containing (a) 0.1-5 masspercent of phenylbenzimidazole sulfonic acid, and (b) N,N, N′,N′-tetrax(2-hydroxypropyl) ethylene diamine. WO12090581 directed to anoil-in-water emulsion sunscreen cosmetic comprising (a) to (e).Component (a) is an acrylic acid/alkyl methacrylate copolymer; (b) is ablock type alkylene oxide derivative, (c) is a UV absorber; (d) is anoil; and (e) is water. WO12086579 directed to a W/O emulsion typecosmetic which comprises: (A) 0.1-5 mass percent of apolyoxyalkylene/alkyl co-modified silicone; (B) 0.1-5 mass percent of apolyoxyalkylene modified silicone, (C) 0.1-60 mass percent of a powder;(D) 3-50 mass percent of a volatile oil component; (E) 10-35 masspercent of glycerin; and (F) water. WO12081446 directed to anoil-in-water emulsion sunscreen composition which is characterized bybeing formed from an oil-in-water emulsion that contains (A) an alkylphosphate salt and (B) an ultraviolet absorbent and has oil globuleshaving a number average particle diameter of less than 130 nm byhigh-shear processing. WO12077639 directed to an oil-in-water typeeyelash cosmetic comprising 1 to 20 mass percent of (a) apentaerythritol ester having a melting point of 30 to 45 degrees C.; 5to 35 mass percent of (b) a wax; and 5 to 45 mass percent of (c) awater-soluble coating agent. WO12073928 directed to a W/O emulsioncomposition comprising (A) plate-shaped particles of an organicallymodified clay mineral which have a mean thickness of 0.1 micrometres orless and a mean length of 0.5 to 50 micrometres and (B) a branched-chainsilicone which is co-modified with both polyoxyalkylene and alkyl; andhaving a viscosity of 10,000 mPa·s or less. WO12070309 directed to anoil-in-water type emulsified cosmetic for sunscreen comprisingcomponents (A) to (F). (A) zinc oxide, (B) volatile oil, (C) higherfatty acid in a liquid state, (D) silicone or sugar ester containing acarboxyl group in the structure, (E) nonionic detergent, and (F) water.US2013189335 directed to an oil-in-water emulsified compositioncomprising miniaturized emulsified particles formed by means of highpressure emulsification, and further comprising (A) salt type drug (B)hydrophilic nonionic surfactant (C) N-long chain acyl acidic amino acidmono salt (D) two or more types of higher fatty acids and alkali thatconstitutes higher fatty acid soap (E) higher alcohol (F) oil component(G) water. WO12056959 directed to an oil-in-water type sunscreencosmetic comprising a polyether-denatured silicone (A), 3-8 mass percentof a filler (B) and an ultraviolet absorber (C), the ultravioletabsorber having an absorptive capacity in the UV-A range. US2013231401directed to an oil-in-water external skin preparation of comprising (a)an aqueous phase containing resin particles, (b) an oil phase, and (c) asurfactant comprising one or more selected from polyoxyethylenehydrogenated castor oil, silicone-type surfactants, and sulfonicacid-type surfactants. US2014148516 directed to a water-in-oil typeemulsified cosmetic comprising: (A) 20 to 30 mass percent of an oilcomponent; (B) a fatty acid ester having an HLB of 5 to 10; (C) anonionic surfactant having an HLB of 1 to 4; (D) an organic modifiedclay mineral; and (E) water. WO12046500 directed to an oil-in-water typeemulsion composition comprising components (a) to (e) below: (a) anacrylic acid-methacrylic acid alkyl copolymer, (b) a block-type alkyleneoxide derivative, (c) a nonionic surfactant, (d) oil, and (e) water.WO12043614 directed to an oil-in-water type emulsion cosmeticcomprising: (A) 0.1-10 mass percent of a polyether-denatured siliconehaving an HLB (Si) of 5-10; (B) 5-50 mass percent inclusive of ethanol;(C) 0.01-3 mass percent of a hydrophilic thickener; (D) 0.1-15 masspercent of a polyol; and (E) a water-soluble whitening agent.US2013142853 directed to a skin cosmetic comprising agar hydrogelparticles having an average particle size of 0.2-5 mm. WO12035904directed to composition comprising an agent for promoting hyaluronicacid production selected from Dioscorea esculenta or an extract thereof.US2013121939 directed to a water-in-oil emulsified cosmetic thatcharacteristically comprises (a) isododecane 3.0-30 wt percent (b)dodecamethylcyclohexasiloxane 1.0-10 wt percent (c) alkyl/polyethercomodified silicone and (d) one or more ultraviolet absorbents selectedfrom 2-hydroxy-4-methoxybenzophenone and diethylamino hydroxybenzoylhexyl benzoate. WO12017733 directed to a skin cosmetic for improvingskin disorders comprising (A) one or more D-amino acid, derivativeand/or salt thereof, (B) hydrogenated phospholipid in which the contentof phosphatidylcholine is 50 percent by mass or more, and (C) awater-soluble polyalcohol, preferably glycerin. As mentioned previously,the compositions as disclosed herein may include any of the formulationsdescribed and/or claimed in the above-stated patent documents, inaddition to silver particles at, e.g., a concentration of 5-50 ppm, orat 10-40 ppm, or at 15-30 ppm, or at 20-25 ppm (parts per million) inthe formulation.

Methods of Use

The present invention provides silver particle-containing emulsions andthe use thereof. For example, the compositions of the present disclosuremay be used for any of pharmaceutical, dermatological or cosmeticpurposes.

In one embodiment, the compositions of the present disclosure may beused as skin care compositions. More specifically, the compositions ofthe present disclosure may be incorporated into bathing products, soaps,antiperspirants; deodorants such as sticks, soft solid, roll on,aerosol, and pump sprays; skin creams; skin care lotions; moisturizers;facial treatments such as wrinkle control or diminishment treatments;exfoliates; body and facial cleansers; bath oils; perfumes; colognes;sachets; sunscreens; mousses; patches; pre-shave and after-shavelotions; shaving soaps; shaving lathers; depilatories; make-ups; colorcosmetics; foundations; concealers; blushes; lipsticks; eyeliners;mascaras; oil removers; color cosmetic removers, powders, and kitsthereof.

The cosmetic compositions may be utilized according to standard methodsfor such products, such as by applying them to the human or animal body,e.g. skin or hair, using applicators, brushes, applying by hand, pouringthem and/or possibly rubbing or massaging the composition onto or intothe body. Removal methods, for example for colour cosmetics are alsowell known standard methods, including washing, wiping, peeling and thelike.

The cosmetic compositions may be used on skin in a conventional manner.An effective amount of the composition for the purpose is applied to theskin. Such effective amounts generally range from about 1 mg/cm to about3 mg/cm. Application to the skin typically includes working the cosmeticcomposition into the skin. This method for applying to the skincomprises the steps of contacting the skin with the cosmetic compositionin an effective amount and then rubbing the composition into the skin.These steps can be repeated as many times as desired to achieve thedesired benefit.

Benefits obtained from using the cosmetic compositions on skin includeone or more of the following benefits: skin softness, suppleness,moisturisation, skin feel, and foam generation. In addition, oralternatively, the compositions of the present disclosure may be used torejuvenate skin, where this term refers to the full or partial reversalof at least one phenotype typical of an aging cell. Skin rejuvenationcan include one or more of the following: reducing the appearance offine lines and wrinkles; reducing deep wrinkles; enhancing skin tone andelasticity; reducing skin blemishes and/or age spots; reducing skinroughness; and producing a younger looking skin.

The compositions of the present disclosure may help soothe, hydrate andrejuvenate the skin. The compositions of the present invention may helpto promote natural healing and rejuvenate the skin. The compositions ofthe present invention may help the skin to feel softer. These areexamples of the healing benefits provided by the formulations of thepresent disclosure. These benefits may be provided by the serums,lotions, creams, ointments and other forms of the emulsions of thepresent disclosure that contain particulate silver.

Analytical Methods

The analysis of the silver content in the compositions of this inventionmay be done by atomic absorption (AA), inductively coupled plasma/atomicemission (ICP/AES), or other techniques known to one of ordinary skillin the art to be sensitive to silver in the appropriate concentrationrange. If the particles of the silver composition are small anduniformly sized (for example, 0.01 micrometers or less), a reasonablyaccurate assay may be obtained by running the colloid directly by AA orICP/AES. This is because the sample preparation for AA ionizesessentially all of the silver allowing its ready detection. If thecompositions comprise particles as large as 0.2 micrometers, it ispreferred to use a digestion procedure. The digestion procedure is notnecessarily ideal for silver compositions that may have beenmanufactured or stored in contact with halides or other anionic speciesthat may react with finely divided silver, or combined with protein orother gelatinous material.

An embodiment of the digestion procedure is as follows: (a) take a 10 mlaliquot of a thoroughly mixed or shaken silver composition to beanalyzed, and place it in a clean glass bottle or other container ofsuitable material (generally, the bottle) with a tight fitting lid. Asize of 30-100 ml is preferred; (b) with a micropipette or dropper, add0.1 ml of nitric acid, reagent grade to the silver composition in thebottle; (c) with the lid of the bottle tightly in place, heat thecomposition to 80° C. with mild agitation for a time sufficient todissolve the silver-dissolution is essentially instantaneous; (d) allowthe resulting mixture to cool to room temperature with the lid in place.Shake the bottle thoroughly; (e) utilize AA, ICP/MS, or equivalent meansto analyze the silver content of the composition. Preferably, one willutilize a freshly prepared standard or standards, preferably preparedaccording the equipment manufacturer's instructions, with appropriatedilution as needed. When reporting results, one must take into accountall dilutions during preparation, including the 1% dilution caused byaddition of the nitric acid.

The analysis of the physical and chemical form of the silver in thecompositions may be done by time-of-flight secondary ion massspectrometry (TOF-SIMS). The TOF-SIMS technique is suitably used as asurvey tool to identify the composition of unknown samples. It iscapable of quantification if the appropriate microanalytical standardsare available for calibration. To perform TOF-SIMS analysis, a few dropsof a silver-containing composition are evaporated to dryness on asilicon substrate at ambient temperature. The residue is analyzed byTOF-SIMS. A reference silver (II) oxide (AgO) material is analyzed byplacing a few particles of the reference powder as received from thevendor on a silicon substrate, and is denoted as the reference. Thetime-of-flight secondary ion mass spectrometry technique (TOF-SIMS) isbased on the principle of bombarding a solid sample with a pulsed,finely focused beam of primary ions, and then analyzing the secondaryions produced from the surface of the sample via a time-of-flight massspectrograph. This analytical technique is surface sensitive, derivingits information from a layer that extends to approximately 20 to 40 Åbelow the surface.

Size/Morphology/Composition Analysis may be performed by any of SEM, EDS(EDAX) and TEM. In particular, the silver/water compositions may bedried and placed on an EM grid and examined in an SEM (i.e., ScanningElectron Microscope) and two different TEMs (i.e., Transmission ElectronMicroscopes). For example, a silver/water composition may be placed ontoC-film and examined by a cryo-TEM at a temperature of about −100° C.using a power level of approximately 100 kV. The silver/watercomposition of the present invention was therefore substantiallyinstantly frozen. As another example, TEM analysis may be performed inthe “SAD” mode. As yet another example, an EDAX spectrum (i.e., anEnergy Dispersion Spectrum or “EDS”) of silver particles taken fromsilver/water compositions of the present invention may be used to checkfor metallic contaminants. In one aspect, the colloidal silver particlesdo not contain gold or platinum.

It is to be understood that the terminology used herein is for thepurpose of describing specific embodiments only and is not intended tobe limiting. It is further to be understood that unless specificallydefined herein, the terminology used herein is to be given itstraditional meaning as known in the relevant art.

Reference throughout this specification to “one embodiment” or “anembodiment” and variations thereof means that a particular feature,structure, or characteristic described in connection with the embodimentis included in at least one embodiment. Thus, the appearances of thephrases “in one embodiment” or “in an embodiment” in various placesthroughout this specification are not necessarily all referring to thesame embodiment. Furthermore, the particular features, structures, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

The present disclosure provides the following exemplary embodiments:

-   -   1) A formulation comprising colloidal silver particles and an        emulsion phase.    -   2) The formulation of embodiment 1 in the form of a lotion.    -   3) The formulation of embodiment 1 in the form of a skin lotion.    -   4) The formulation of embodiment 1 in the form of a cream.    -   5) The formulation of embodiment 1 in the form of a skin cream.    -   6) The formulation of embodiment 1 in the form of an ointment.    -   7) The formulation of embodiment 1 in the form of a healing        ointment.    -   8) The formulation of embodiment 1 in the form of a serum.    -   9) The formulation of embodiment 1 in the form of an anti-aging        serum.    -   10) The formulation of embodiment 1 which is a cosmetic        formulation.    -   11) The formulation of embodiment 1 which is a dermatologic        formulation.    -   12) The formulation of embodiment 1 which is a therapeutic        formulation.    -   13) The formulation of embodiment 1, or any of embodiments 2-12,        wherein the silver particles range in size from 1 to 100        nanometers.    -   14) The formulation of embodiment 1, or any of embodiments 2-12,        wherein the silver particles comprises a silver core surrounded        by a multivalent silver oxide coating comprised of Ag₄O₄        molecules, optionally further described by any one or more of        embodiments 13 (wherein the silver particles range in size from        1-100 nanometers), embodiment 15 (having a concentration of        silver particles of 1-100 ppm), embodiment 16 (wherein the        silver is characterized by particle size, and more than 50% of        the silver particles have a maximum dimension of less than 0.015        micrometers), and/or embodiment 17 (having a total concentration        of silver particles of between about 5 parts per million and 40        parts per million, wherein said silver is in the form of a        stable and colorless colloidal suspension of silver particles        having an interior of metallic silver and an exterior surface of        silver oxide, optionally ionic silver oxide, wherein at least        75% of the silver particles have diameters between 0.005        micrometers and 0.015 micrometers).    -   15) The formulation of embodiment 1, or any of embodiments 2-12,        having a concentration of silver particles of 1-100 ppm,        optionally further described by any one or more embodiment 13,        embodiment 14, embodiment 16, and/or embodiment 17.    -   16) The formulation of embodiment 1, or any of embodiments 2-12,        wherein the silver is characterized by particle size, and more        than 50% of the silver particles have a maximum dimension of        less than 0.015 micrometers, optionally further described by any        one or more of embodiment 13, embodiment 14, embodiment 15,        and/or embodiment 17.    -   17) The formulation of embodiment 1, or any of embodiments 2-12,        having a total concentration of silver particles of between        about 5 parts per million and 40 parts per million, wherein said        silver is in the form of a stable and colorless colloidal        suspension of silver particles having an interior of metallic        silver and an exterior surface of silver oxide, optionally ionic        silver oxide, wherein at least 75% of the silver particles have        diameters between 0.005 micrometers and 0.015 micrometers.    -   18) The formulation of embodiment 1, or any preceding        embodiment, comprising an oil.    -   19) The formulation of embodiment 1, or any preceding        embodiment, comprising an oil selected from coconut oil, hemp        seed oil, argan oil, shea butter, sunflower seed oil, neem oil,        jojoba oil, and sweet almond oil.    -   20) The formulation of embodiment 1, or any preceding        embodiment, comprising a fatty acid.    -   21) The formulation of embodiment 1, or any preceding        embodiment, comprising a fatty acid selected from C10-C28 fatty        acids.    -   22) The formulation of embodiment 1, or any preceding        embodiment, comprising an emulsifying wax.    -   23) The formulation of embodiment 1, or any preceding        embodiment, comprising a surfactant.    -   24) The formulation of embodiment 1, or any preceding        embodiment, comprising hyaluronic acid.    -   25) The formulation of embodiment 1, or any preceding        embodiment, comprising a pH adjusting agent.    -   26) The formulation of embodiment 1, or any preceding        embodiment, comprising a pH adjusting agent selected from        ethanolamine, diethanolamine and triethanolamine.    -   27) The formulation of embodiment 1, or any preceding        embodiment, comprising a component that treat, prevents or        controls acne.    -   28) The formulation of embodiment 1, or any preceding        embodiment, comprising a component that imparts lubricity to the        composition.    -   29) A method of improving skin comprising administering an        effective amount of a formulation according to any of        embodiments 1-28 to skin.    -   30) A method of making an emulsion comprising combining an        aqueous phase and an oil phase, where the aqueous phase        comprises particulate silver.    -   31) The method of embodiment 30 wherein the water phase is added        to the oil phase to provide a water-in-oil emulsion.    -   32) The method of embodiment 30 wherein the oil phase is added        to the water phase to provide an oil-in-water emulsion.    -   33) A personal lubricant composition comprising colloidal silver        particles, water, and a thickening agent for the water, where        the thickening agent is optionally hydroxyl ethyl cellulose.    -   34) An acne treatment medicament comprising colloidal silver        particles, water, an exfoliant optionally selected from        salicylic acid and glycolic acid, and an alcohol optionally        selected from ethanol, propylene glycol and polyethylene glycol.

In each of the embodiments described herein, including each of thenumbered embodiments 1-34) set forth above, any of the formulations mayinclude silver in the +2 (also known as 2+ or Ag (II)) oxidation state.As mentioned previously, it has been surprisingly found that theselection of silver particles comprising silver in the +2 oxidationstate affords a superior formulation. Silver particles in the +2oxidation state may be used in a low concentration that providesdesirable benefits for the formulation, e.g., desirable anti-microbialbenefits, and this low concentration does not cause undesirable effectsor side-reactions that are observed at higher silver concentration.Thus, the present disclosure provides formulations that contain silverparticles comprising silver in the +2 oxidation state, the particlesbeing present in the formulation within a stated concentration rangehaving a minimum and maximum concentration, where the minimumconcentration is selected from 0.01 ppm, or 0.02 ppm, or 0.03 ppm, or0.04 ppm, or 0.05 ppm, or 0.06 ppm, or 0.07 ppm, or 0.08 ppm, or 0.09ppm, or 0.1 ppm, or 0.2 ppm, or 0.3 ppm, or 0.4 ppm, or 0.5 ppm, or 0.6ppm, or 0.7 ppm, or 0.8 ppm, or 0.9 ppm, or 1 ppm, or 2 ppm, or 3 ppm,or 4 ppm, or 5 ppm, or 6 ppm, or 7 ppm, or 8 ppm, or 9 ppm, or 10 ppm,and the maximum concentration is selected from 1,000 ppm, or 500 ppm, or400 ppm, or 300 ppm, or 200 ppm, or 100 ppm, or 90 ppm, or 80 ppm, or 70ppm, or 60 ppm, 50 ppm, or 40 ppm, or 30 ppm, or 25 ppm, or 20 ppm, or15 ppm, or 10 ppm. Exemplary silver particle concentrations of 1-100ppm, or 0.5-500 ppm, or 0.1-1,000 ppm, or less than 20 ppm, or less than50 ppm, or 10-35 ppm are provided by the present invention, as well asconcentrations within 1-100 ppm as mentioned previously. A benefit ofusing silver (II) at low concentration includes providing a product witha longer shelf life, e.g., providing a product that retains the desiredperformance benefit for a longer period of time, or providing a productthat retains its consistency for a longer period of time, or providing aproduct that retains its original color for a longer period of time,since unwanted oxidation reactions that can shorten shelf life and/ordamage the consistency of the product, and/or cause discoloration, arereduced. For example, the formulation may have at least about 10 ppmsilver particles in order to provide good antimicrobial effectivenessbut less than about 32 ppm silver particles in order to avoiddiscoloration of the formulation. Consistency in coloration and/orrheology over time may be measured while the formulation sits at roomtemperature, for example about 23° C., for a period of time, forexample, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 1 week, 2 weeks,3 weeks, 4 weeks, 1 month, 2 months, 3 months, 4 months, 5 months or 6months. Coloration and rheology may also be evaluated relative to targetvalues. For example, if a white product is desired, and the silverconcentration is too high, then a grey or yellowish product may result,indicating that too high of a concentration of silver is present in theformulation. In one embodiment, the silver particles used in the presentformulations do not include any substantial amount of silver in the +1oxidation state, but only has silver in the silver metal or +2 oxidationstate, or if silver in the +1 oxidation state is present, it is presentin a minor amount, i.e., less than the amount of silver present in the+2 oxidation state. Optionally, the particles contain a thin multivalentsilver oxide coating, built of numerous Ag₄O₄ molecules which surround ametallic nano-sized silver core. With the Ag₄O₄ coating, the nano silverparticle may become attracted to the surrounding water molecules, and assuch, becomes part of the structure of the water. Within optionalembodiments of the invention these particles can range in size from1-100 nanometers, or from 1-10 nanometers, or from 5-7 nanometers.Moreover, within preferred embodiments the particles are surrounded by amultivalent silver oxide coating comprised of Ag₄O₄ molecules.

Unless the context requires otherwise, throughout the specification andclaims that follow, the word “comprise” and synonyms and variantsthereof such as “have” and “include”, as well as variations thereof suchas “comprises” and “comprising” are to be construed in an open,inclusive sense, e.g., “including, but not limited to.” The term“consisting essentially of” limits the scope of a claim to the specifiedmaterials or steps, or to those that do not materially affect the basicand novel characteristics of the claimed invention.

Any headings used within this document are only being utilized toexpedite its review by the reader, and should not be construed aslimiting the invention or claims in any manner. Thus, the headings andAbstract of the Disclosure provided herein are for convenience only anddo not interpret the scope or meaning of the embodiments.

In the foregoing description, certain specific details are set forth toprovide a thorough understanding of various disclosed embodiments.However, one skilled in the relevant art will recognize that embodimentsmay be practiced without one or more of these specific details, or withother methods, components, materials, etc.

The Examples and preparations provided below further illustrate andexemplify the formulations of the present invention and methods ofpreparing such formulations. It is to be understood that the scope ofthe present invention is not limited in any way by the scope of thefollowing Examples and preparations. In the following Examples, thestarting materials and various reactants utilized or referenced in theexamples may be obtained from commercial sources, or are readilyprepared from commercially available organic compounds, using methodswell-known to one skilled in the art.

The following examples are included to demonstrate preferred embodimentsof the invention. It should be appreciated by those of skill in the artthat the techniques disclosed in the examples which follow representtechniques discovered by the inventor to function well in the practiceof the invention, and thus can be considered to constitute preferredmodes for its practice. However, those of skill in the art should, inlight of the present disclosure, appreciate that many changes can bemade in the specific embodiments which are disclosed and still obtain alike or similar result without departing from the spirit and scope ofthe invention. All percentages are in wt. %. All measurements wereconducted at 23° C. unless indicated otherwise.

EXAMPLES

General Procedures: The efficacy of the colloidal silver particles as apreservative for the lotions and creams of the present disclosure wastested according to the procedure described in the United StatesPharmacopeia (USP 36) National Formulary, General Chapter 51, as theAntimicrobial Effectiveness Test (AET). This test is sometimes referredto as preservative challenge testing. The AET method challengespreserved products with a variety of microorganisms representing aspectrum of manufacturing, nosocomial and household contaminants, wheresuch microorganisms may include gram-negative and gram-positivebacteria, yeast and mold species.

The AET method was used herein to challenge (inoculate) the lotions andcreams of the present disclosure with 6 different microorganisms:Candida albicans (ATCC 10231, a yeast, which is a form of fungus);Escherichia coli (ATCC 8739, a bacterium also known as “E. coli”);Staphylococcus aureus (ATCC 6538, a bacterium also known as “Staph”);Pseudomonas aeruginosa (ATCC 9027, a bacterium); Staphylococcus aureussubsp. aureus Rosenbach (ATCC 43300, a bacterium, also known asMethicillin Resistant Staphylococcus aureus (MRSA)); and Enterococcusfaecalis (ATCC 51299, also known as Vanomycin Resistant Enterococcus(VRE)).

A sufficient volume of test product (typically 10 ml) is distributedinto each of 5 separate containers, and each container is inoculatedwith a separate test microorganism (mentioned above). The initialconcentration of viable microorganisms in the test product is determinedby standard dilution and plate count methods. Inoculated test productsare incubated at 22.5±2.5° C. and sampled to determine microorganismconcentration at time intervals. The microorganism concentration at eachinterval is compared to the initial concentration, and then preservativeeffectiveness is determined based USP guidelines

The results from the AET of the lotion of Example 1 and the cream ofExample 2 are provided in Tables 1 (A and B) and 2 (A and B),respectively. In Tables 1 and 2, “Initial” refers to the initialconcentration of the microorganism added to the lotion (Table 1) orcream (Table 2) having the corresponding ATCC reference number; “L.R.”refers to Log Reduction; “min.” refers to minutes; and “k” refers tothousand.

Example 1 Preparation of Cosmetic Lotion Having an Oil-in-Water Emulsion

ASAP10 Silver Solution™ (ABL Manufacturing LLC, American Fork, Utah,USA) is heated to 120° F. with vigorous agitation. Hyaluronic acid isslowly added to the hot silver solution and then the mixture is stirredfor about 1 hour until it becomes clear. In a separate container,emulsifying wax and stearic acid are melted together using microwaveheating in 30-45 second bursts until a melt is achieved. Coconut oil isthen added to the molten mixture with stirring to provide a homogeneousmelt. If needed, additional microwave heating may be applied in order tomaintain the melt at about 120° F. Vitamin E is then added to the moltenmixture with stirring, and additional heating is applied as needed toprovide a homogeneous molten oil phase at about 120° F. With both theaqueous and oil mixtures in separate contains at 120° F., the oilmixture is gradually added to the vigorously stirred aqueous solution.The mixture is continually stirred until a homogeneous oil in wateremulsion forms; typically 5-10 minutes of additional stirring is needed.This emulsion is a cosmetic lotion according to the present disclosure.

This cosmetic lotion was submitted for preservative challenge testingperformed according to the procedure described in the United StatesPharmacopeia (USP 36) National Formulary, General Chapter 51, as theAntimicrobial Effectiveness Test (AET). The results are provided inTable 1A (for testing 10 minutes, 60 minutes and 4 hours afterinoculation) and Table 1B (for testing 1 day, 7 days and 28 days afterinoculation), and show that the silver-containing lotion of the presentdisclosure has good resistance to microorganism growth.

TABLE 1A Concentration of ATCC-identified microorganism at predeterminedtime points after inoculation 10 60 240 ATCC Initial min. L.R. min. L.R.min. L.R. 43300 5.2 × 10⁵ >30k <1.24 >30k <1.24 >30k <1.24 51299 8.9 ×10⁵ 50 4.25  12k 1.87 200 3.65 9027 7.7 × 10⁵ 300 3.41 300 3.41 150 3.718739 6.8 × 10⁵ 2500 2.43  3k 2.36 600 3.05 10231 9.9 × 10⁵ 30 4.52  504.30 <10 <5.04 6538 6.3 × 10⁵ >30k <1.32 >30k <1.32 800 2.90

TABLE 1B Concentration of ATCC-identified microorganism at predeterminedtime points after inoculation 1 7 28 ATCC Initial day L.R. days L.R.days L.R. 43300 6.1 × 10⁵ >30k <1.31 <10 >4.83 <10 >4.83 51299 5.8 × 10⁵<10 >4.81 <10 >4.81 <10 >4.81 9027 8.2 × 10⁵ <10 >3.96 <10 >3.96<10 >3.96 8739 7.3 × 10⁵ <10 >4.91 <10 >4.91 <10 >4.91 10231 6.1 × 10⁵<10 >4.83 <10 >4.83 <10 >4.83 6538 4.2 × 10⁵ <10 >4.67 <10 >4.67 <10>4.67

Example 2 Preparation of Cosmetic Cream having an Oil-in-Water Emulsion

ASAP10 Silver Solution™ (ABL Manufacturing LLC, American Fork, Utah,USA) is heated to 120° F. with vigorous agitation. Hyaluronic acid isslowly added to the hot silver solution and then the mixture is stirredfor about 1 hour until it becomes clear. In a separate container,emulsifying wax and stearic acid are melted together using microwaveheating in 30-45 second bursts until a melt is achieved. Coconut oil isthen added to the molten mixture with stirring to provide a homogeneousmelt. If needed, additional microwave heating may be applied in order tomaintain the melt at about 120° F. Vitamin E is then added to the moltenmixture with stirring, and additional heating is applied as needed toprovide a homogeneous molten oil phase at about 120° F. With both theaqueous and oil mixtures in separate contains at 120° F., the oilmixture is gradually added to the vigorously stirred aqueous solution.The mixture is continually stirred until a homogeneous oil in wateremulsion forms; typically 5-10 minutes of additional stirring is needed.This emulsion is a cosmetic lotion according to the present disclosure.

This cosmetic lotion was submitted for preservative challenge testingperformed according to the procedure described in the United StatesPharmacopeia (USP 36) National Formulary, General Chapter 51, as theAntimicrobial Effectiveness Test (AET). The results are provided inTable 2A (for testing 10 minutes, 60 minutes and 4 hours afterinoculation) and Table 2B (for testing 1 day, 7 days and 28 days afterinoculation), and show that a silver-containing lotion of the presentdisclosure has good resistance to microorganism growth.

TABLE 2A Concentration of ATCC-identified microorganism at predeterminedtime points after inoculation 10 60 240 ATCC Initial min. L.R. min. L.R.min. L.R. 43300 5.2 × 10⁵ >30k <1.24 25k 1.32 300 3.24 51299 8.9 × 10⁵<10 >5.0 <10 >5.0 <10 >5.0 9027 7.7 × 10⁵ <10 >4.93 <10 >4.93 <10 >4.938739 6.8 × 10⁵ 50 4.13 <10 >4.88 40 4.23 10231 9.9 × 10⁵ <10 >5.04<10 >5.04 <10 >5.04 6538 6.3 × 10⁵ 750 2.92 100 3.80 <10 >4.85

TABLE 2B Concentration of ATCC-identified microorganism at predeterminedtime points after inoculation 1 7 28 ATCC Initial day L.R. days L.R.days L.R. 43300 6.1 × 10⁵ <10 >4.83 <10 >4.83 <10 >4.83 51299 5.8 × 10⁵<10 >4.81 <10 >4.81 <10 >4.81 9027 8.2 × 10⁵ <10 >3.96 <10 >3.96<10 >3.96 8739 7.3 × 10⁵ <10 >4.91 <10 >4.91 <10 >4.91 10231 6.1 × 10⁵<10 >4.83 <10 >4.83 <10 >4.83 6538 4.2 × 10⁵ <10 >4.67 <10 >4.67 <10>4.67

Example 3 Preparation of Sunscreen having an Oil-in-Water Emulsion

ASAP10 Silver Solution™ (ABL Manufacturing LLC, American Fork, Utah,USA, 60 wt % of the product sunscreen) is heated to 120° F. withvigorous agitation. In a separate container, emulsifying wax (8 wt %) ismelted using microwave heating in 30-45 second bursts until a melt isachieved. Coconut oil (2 wt %) is then added to the molten mixture withstirring to provide a homogeneous melt. If needed, additional microwaveheating may be applied in order to maintain the melt at about 120° F.Ascorbic acid (0.5 wt %) and glycerin (2 wt %) are then added to themolten mixture with stirring, and additional heating is applied asneeded to provide a homogeneous molten oil phase at about 120° F. Zincoxide (25 wt %) is then stirred into this molten mixture. With both theaqueous and oil mixtures in separate contains at 120° F., the oilmixture is gradually added to the vigorously stirred aqueous solution.The mixture is continually stirred until a homogeneous oil in wateremulsion forms; typically 5-10 minutes of additional stirring is needed.This emulsion is a sunscreen according to the present disclosure.

Example 4 Preparation of Personal Lubricant

ASAP10 Silver Solution™ (ABL Manufacturing LLC, American Fork, Utah,USA, 98 wt % of the product lubricant) is combined with 2 wt % ofhydroxy ethyl cellulose and with vigorous stirring to provide a viscouscomposition useful as a personal lubricant.

Example 5 Preparation of Acne Medication

ASAP10 Silver Solution™ (ABL Manufacturing LLC, American Fork, Utah,USA, 50 wt % of the product acne medication) is combined with a mixtureof propylene glycol (35 wt %), ethanol (10 wt %), glycolic acid (3 wt %)and salicylic acid (2 wt %) with stirring to provide a compositionuseful as an acne medication.

Example 6 Preparation of Acne Medication

ASAP10 Silver Solution™ (ABL Manufacturing LLC, American Fork, Utah,USA, 75 wt % of the product acne medication) is combined with a mixtureof polyethylene glycol 400 (20 wt %), glycolic acid (3 wt %) andsalicylic acid (2 wt %) with stirring to provide a composition useful asan acne medication.

Example 7 Preparation of Acne Medication

ASAP10 Silver Solution™ (ABL Manufacturing LLC, American Fork, Utah,USA, 75.5 wt % of the product acne medication) is combined with amixture of polyethylene glycol 400 (10 wt %), propylene glycol (10 wt%), salicylic acid (2 wt %), glycolic acid (2 wt %), Carbopol Ultrez 30™(a cross-linked homopolymer of acrylic acid with thickening properties;1.5 wt %) and sodium hydroxide (1 wt %) with stirring to provide acomposition useful as an acne medication.

Although any methods and materials similar or equivalent to thosedescribed herein can also be used in the practice or testing of thepresent invention, a limited number of the exemplary methods andmaterials are described herein.

Where a range of values is provided herein, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges is also encompassed within the invention, subject to anyspecifically excluded limit in the stated range. Where the stated rangeincludes one or both of the limits, ranges excluding either or both ofthose included limits are also included in the invention.

For example, any concentration range, percentage range, ratio range, orinteger range provided herein is to be understood to include the valueof any integer within the recited range and, when appropriate, fractionsthereof (such as one tenth and one hundredth of an integer), unlessotherwise indicated. Also, any number range recited herein relating toany physical feature, such as polymer subunits, size or thickness, areto be understood to include any integer within the recited range, unlessotherwise indicated. As used herein, the term “about” means±20% of theindicated range, value, or structure, unless otherwise indicated.

All of the U.S. patents, U.S. patent application publications, U.S.patent applications, foreign patents, foreign patent applications andnon-patent publications referred to in this specification and/or listedin the Application Data Sheet, are incorporated herein by reference, intheir entirety. Such documents may be incorporated by reference for thepurpose of describing and disclosing, for example, materials andmethodologies described in the publications, which might be used inconnection with the presently described invention. The publicationsdiscussed above and throughout the text are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the inventors are notentitled to antedate any referenced publication by virtue of priorinvention.

In general, in the following claims, the terms used should not beconstrued to limit the claims to the specific embodiments disclosed inthe specification and the claims, but should be construed to include allpossible embodiments along with the full scope of equivalents to whichsuch claims are entitled. Accordingly, the claims are not limited by thedisclosure. From the foregoing it will be appreciated that, althoughspecific embodiments of the invention have been described herein forpurposes of illustration, various modifications may be made withoutdeviating from the spirit and scope of the invention. Accordingly, theinvention is not limited except as by the appended claims.

What is claimed is:
 1. A formulation in a form selected from a lotionand a cream, the formulation comprising colloidal silver particles,hyaluronic acid, coconut oil, octadecaonic acid, glycerin, vitamin E,and an emulsifying wax at a concentration of 3-10 wt % to stabilize anemulsion phase.
 2. The formulation of claim 1 which is selected from acosmetic formulation, a dermatologic formulation, and a therapeuticformulation.
 3. The formulation of claim 1 wherein the silver particlesrange in size from 1-100 nanometers.
 4. The formulation of claim 1wherein the silver is characterized by particle size, and more than 50%of the silver particles have a maximum dimension of less than 0.015micrometers.
 5. The formulation of claim 1 wherein the silver particlescomprises a metallic silver core surrounded by a multivalent silveroxide coating comprised of Ag₄O₄ molecules.
 6. The formulation of claim1 having a concentration of silver particles of 10-40 ppm.
 7. Theformulation of claim 1 having a total concentration of silver particlesof between about 5 parts per million and 40 parts per million, whereinsaid silver is in the form of a stable and colorless colloidalsuspension of silver particles having an interior of metallic silver andan exterior surface of silver oxide, optionally ionic silver oxide,wherein at least 75% of the silver particles have diameters between0.005 micrometers and 0.015 micrometers.
 8. The formulation of claim 1comprising a component that treat, prevents or controls acne.
 9. Theformulation of claim 1 comprising a component that imparts lubricity tothe composition.
 10. A method of improving skin comprising administeringan effective amount of a formulation according to claim 1 to skin.
 11. Amethod of making a formulation of claim 1 comprising combining anaqueous phase and an oil phase, where the aqueous phase comprisesparticulate silver, to provide an emulsion having from 10 to 40 ppm ofsilver particles.
 12. The method of claim 11 wherein the aqueous phaseis added to the oil phase to provide a water-in-oil emulsion.
 13. Themethod of claim 11 wherein the oil phase is added to the aqueous phaseto provide an oil-in-water emulsion.